Medicine guide

Lidocaine Hydrochloride and Hydrocortisone Acetate

30 mg/g + 25 mg/g · Gel

Prescription only
Amide Local Anesthetic

Active substance: Lidocaine Hydrochloride and Hydrocortisone Acetate
Used in: Pain, sleep, mood, epilepsy and the brain
Made by: Seton Pharmaceuticals
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-01-30

What it is

Amide Local Anesthetic

Do not take it if

Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

3other products contain Lidocaine Hydrochloride and Hydrocortisone Acetate — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Medicine groupPain, sleep, mood, epilepsy and the brain

This information is not included in the verified source. Open the official leaflet

How it works

From this product’s own US prescribing label.

Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action.
Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-01-30

Do not take it if

Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics.
If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician.
Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease.
Product should be used with caution on patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic.
These products are contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Apply product to the affected area(s) twice daily or as directed by a physician.
Product should not be used in excess of recommendations or for prolonged use in the anal canal.
If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician.
Patient Directions for Rectal Administration:
Remove moist wipe from box, tear open the package, gently clean the affected area and discard moist wipe.
(Note:
The moist wipe does not contain any of the prescribed active ingredients.) The cap and foil seal should be removed from the tube and the applicator tip firmly screwed onto the end of the tube and tightened.
(Do not over tighten.) While holding the tube, gently squeeze the tube until a small amount of cream/gel comes out of the applicator openings.
This will lubricate the applicator tip.
Gently insert the applicator tip into anal area.
Continue squeezing the body of the tube as you move it around the areas of discomfort, and lastly, around and in the anal opening (if directed by physician).
Do not completely insert the applicator and tube into the anus or insert deep into the rectum.
Do not insert a loose applicator tip into the anus or rectum.
Once application is completed, the tube and applicator tip should be gently removed and discarded.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

For external use only.
Not for ophthalmic use.
Product, applicators and moist wipes could harm small children if chewed or swallowed.
Keep product, moist wipes and applicators out of the reach of children.
Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use.
Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition.
If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.
Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood.
Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death.
Discontinue [the use of this product] and any other oxidizing agents.
Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration.
More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.
If extensive areas are treated, the possibility of systemic absorption exists.
Systemic absorption of topical steroids has produced reversible hypothalamic pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glycosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of potent topical steroids applied to a large surface area, or under an occlusive dressing, should be evaluated periodically for evidence of HPA axis suppression.
If noted, an attempt should be made to withdraw the drug to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of the HPA axis function is generally prompt and complete upon discontinuation of the drug.
Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionately larger amounts of topical cortico-steroids and thus be more susceptible to systemic toxicity.
If irritation develops, topical steroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted.
If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

IN PREGNANCY: Teratogenic Effects: Pregnancy Category C.
Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine.
There are, however, no adequate and well-controlled studies in pregnant women.
Animal reproduction studies are not always predictive of human response.
General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
There are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Lidocaine is excreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when lidocaine is administered to a nursing woman.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents:
Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine Antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid Antimalarials chloroquine, primaquine Anticonvulsants phenytoin, sodium valproate, phenobarbital Other drugs acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine

Quoted from the official label, section “Drug Interactions”.

Use in children

Safety and efficacy in children have not been established.

Quoted from the official label, section “Pediatric Use”.

Side effects

During, immediately, or following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin.
CALL YOUR DOCTOR ABOUT SIDE EFFECTS.
You may report side effects to the FDA at 1-800-FDA-1088.

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

Lidocaine 3% - Hydrocortisone 2.5% Gel Kit 20 Count Kit, NDC 13925-164-20 Containing:
20 single use ¼ oz (7g) Tubes (NDC 13925-164-07) of Lidocaine 3% - Hydrocortisone 2.5% Gel (a white gel), 20 Applicators and 20 Moist Wipes

Quoted from the official label, section “How Supplied”.

How to store it

SECTION:
Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). See USP Controlled Room Temperature. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Quoted from the official label, section “Storage and Handling”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

aluminum sulfate, calcium acetate, cetyl alcohol, citric acid, glyceryl stearate (and) PEG-100 stearate, methylparaben, mineral oil, PEG-150 distearate, petrolatum, polycarbophil, propylene glycol, propylparaben, purified water, sodium citrate, sodium hydroxide, stearyl alcohol, xanthan gum.

Quoted from the official label, section “Inactive Ingredients”.

What is in it

Lidocaine 3% - Hydrocortisone 2.5% Gel Kit are indicated for the anti-inflammatory and anesthetic relief of itching, pain, soreness, and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Parabensmethylparaben; propylparabenPreservatives some people prefer to avoid or are sensitive to.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (3)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 3 of 3

Details

Made by	Seton Pharmaceuticals
Active substance	Lidocaine Hydrochloride and Hydrocortisone Acetate
Used in	Pain, sleep, mood, epilepsy and the brain
Strength	30 mg/g + 25 mg/g
Form	Gel
Route	Rectal
Packs	20 TUBE in 1 KIT / 7 g in 1 TUBE
NDC	13925-164

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Cream3 products
- 30 mg/g + 5 mg/g2
  30 mg/g + 5 mg/g · 2 companies
  - Seton Pharmaceuticals
  - Westminster Pharmaceuticals, LLC
- 30 mg/g + 10 mg/g
Gel1 products
- 30 mg/g + 25 mg/g

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Lidocaine Hydrochloride and Hydrocortisone Acetate30 mg/g + 5 mg/gPrescription onlyCream Seton Pharmaceuticals · Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate30 mg/g + 10 mg/gPrescription onlyCream Seton Pharmaceuticals · Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate30 mg/g + 5 mg/gPrescription onlyCream Westminster Pharmaceuticals, LLC · Lidocaine Hydrochloride and Hydrocortisone Acetate

See every product with Lidocaine Hydrochloride and Hydrocortisone Acetate