Lidotral 5 Percent and Hydrocortisone 1 Percent with Peptides and Arnica
50 mg/g + 10 mg/g · Cream
- Prescription only
- Amide Local Anesthetic
- Active substance
- Lidocaine Hcl 5 % , Hydrocortisone Acetate 1%
- Made by
- PureTek Corporation
- 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 · 2024-03-15
Amide Local Anesthetic
- The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns.
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 ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns.
- For the relief of redness, pain, itching, discoloration, inflammation and mild skin burns associated with radiation.
- For use after radiation treatment, cosmetic procedures, sun exposure, and for inflammatory skin conditions.
From the official label · 2024-03-15 · DailyMed
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 affecting local anesthetic action.
Hydrocortisone acetate providesrelief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-03-15
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 in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic.
- Product is 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 licensed healthcare practitioner.
- If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician.
- Wash hands before and after application.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- CONCERNS RELATED TO ADVERSE EFFECTS:
- Methemoglobinemia:
- Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents.
- Onset may be immediate or delayed (hours) after anesthetic exposure.
- Patients with G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (including pale, gray, or blue-colored skin (cyanosis), headache, rapid pulse, shortness of breath, lightheadedness, fatigue).
- WARNINGS: For external use only.
- Not for ophthalmic use.
- Stop use and
- ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.
- Do not apply to wounds or damaged skin.
- Do not use in large quantities, particularly over raw surfaces or blistered areas.
- If swallowed, get medical help or contact a Poison Control Center right away.
- Keep out of reach of children.
- Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin.
- Product should not be ingested or applied into the mouth, inside of the nose or in the eyes.
- Product should not be used in the ears.
- Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicated because of ototoxicity associated with lidocaine observed in animals when instilled in the middle ear.
- Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion.
- If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.
- 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, manifestation 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 corticosteroids 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.
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
Safety and efficacy in children have not been established.
Quoted from the official label, section “Pediatric Use”.
Side effects
During or immediately 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.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
Lidotral™ 5% + Hydrocortisone 1% Cream with Peptides & Arnica (Lidocaine HCl 5% - Hydrocortisone Acetate 1%) is supplied as a beige cream in a 3 oz. (85 g) tube - NDC 59088-319-07
Quoted from the official label, section “How Supplied”.
How to store it
- KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
- Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].
Quoted from the official label, section “Storage and Handling”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
Aloe Barbadensis (Aloe) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Bis(Tripeptide-1) Copper Acetate, Brassica Campestris (Rapeseed) Sterols, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Alcohol, Cetyl Alcohol, Coco-Caprylate/Caprate, Coconut Alkanes, Cucumis Sativus (Cucumber) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, D-Alpha-Tocopherol, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Glycine Soja (Soybean) Sterols, Glycolipids, Hydroxyethylcellulose, Menthyl Lactate, PEG-100 Stearate, Phenoxyethanol, Phospholipids, Polyglyceryl-3 Diisostearate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol, Tetrahexyldecyl Ascorbate
Quoted from the official label, section “Inactive Ingredients”.
What is in it
- Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:
- Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula:
- Lidotral™ 5% + Hydrocortisone 1% Cream with Peptides & Arnica Each gram contains Lidocaine HCl 50 mg, Hydrocortisone Acetate 10 mg.
- ACTIVE INGREDIENTS: Lidocaine HCl 5% Hydrocortisone Acetate 1% new image description
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.
- Soy
Glycine Soja (Soybean) Oil; Glycine Soja (Soybean) Sterols
Matters with a soy allergy.
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.
Details
| Made by | PureTek Corporation |
|---|---|
| Active substance | Lidocaine Hcl 5 % , Hydrocortisone Acetate 1% |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 50 mg/g + 10 mg/g |
| Form | Cream |
| Route | Topical |
| Packs | 85 g in 1 TUBE |
| NDC | 59088-319 |
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).