Pharmapurerx Lidocaine Hcl 4.12%
41.2 mg/g · Cream
- Prescription only
- Amide Local Anesthetic
- Active substance
- Lidocaine Hydrochloride
- 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 · 2023-01-11
Not necessarily this product — shortages are reported per presentation. Your pharmacy will know. · Updated 2026-09-22 FDA drug shortages
Amide Local Anesthetic
- For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components.
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
- For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
From the official label · 2023-01-11 · DailyMed
How it works
From this product’s own US prescribing label.
PharmaPureRx ® Lidocaine 4.12% Cream releases lidocaine from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action.
A mild acidic vehicle lowers pH to increase protection against alkaline irritations and to provide a favorable environment for healing.
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 · 2023-01-11
Do not take it if
- Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components.
- Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
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 a thin film to the affected area two or three times daily or as directed by a physician.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- For external use only. Not for ophthalmic use.
- If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.
- PharmaPureRx ® Lidocaine HCl 4.12% Cream should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.
- CARCINOGENESIS, MUTAGENESIS AND IMPAIRMENT OF FERTILITY:
- Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.
- USE IN PREGNANCY: Teratogenic Effects;
- Pregnancy Category B.
- 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.
- NURSINIG MOTHERS: 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.
- PEDIATRIC USE:
- Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.
Quoted from the official label, section “Warnings”.
Side effects
During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
PharmaPureRx ® Lidocaine HCl 4.12% Cream 1 oz. (28.3 g) tube - NDC 59088-594-03 3 oz. (85 g) tube - NDC 59088-371-07
Quoted from the official label, section “How Supplied”.
How to store it
- KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
- Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing. Manufactured in the USA by:
- PureTek Corporation San Fernando, CA 91340 Rev. 37886 04/17
Quoted from the official label, section “Storage and Handling”.
What is in it
- Contains lidocaine HCl 4.12% in a mild acidic vehicle.
- Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:
- Ingredients:
- Each gram of PharmaPureRx ® Lidocaine 4.12% Cream contains Lidocaine HCl USP 4.12%.
- Inactive Ingredients include:
- Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic. 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.
- Parabens
Methylparaben; Propylparaben
Preservatives 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 (4)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 4 of 4
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | PureTek Corporation |
|---|---|
| Active substance | Lidocaine Hydrochloride |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 41.2 mg/g |
| Form | Cream |
| Route | Topical |
| Packs | 1 TUBE in 1 CARTON / 28.3 g in 1 TUBE · 1 TUBE in 1 CARTON / 85 g in 1 TUBE |
| NDC | 59088-594 |
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).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.