3c404ff7-8b88-9f6b-e063-6294a90a2d91
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic
Medication Information
Warnings and Precautions
Warnings (For external use only)
For external use only
Do not use on large areas of the body or on broken, blistered, or abraded skin
Avoid contact with eyes, mouth and mucous membranes
If pregnant or breast feeding, consult a healthcare provider before use
Indications and Usage
Uses
Temporarily helps reduce discomfort from:
Minor burns, Insect bites, Minor skin irritations, Post-shaving or grooming sensitivity
External itching or rash due to dry skin
Dosage and Administration
Adults and children over 12 years:
Apply a thin layer to affected area
not more than 3-4 times daily
Children under 12 years: Consult a doctor before use
Wash hands after application
Description
Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic
Section 50565-1
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and ask a doctor if:
Condition worsens or symptoms persist for more than 7 days
Skin irritation, rash, or allergic reaction occurs
Section 51727-6
Inactive ingredients
Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E), Carbomer, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin
Section 51945-4
Section 55105-1
Purpose ............External analgesic
Section 55106-9
Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic
Section 60561-8
Store at room temperature (15-30°C/59-86'F)
Tamper evident: Do not use if seal is broken or missing
Structured Label Content
Indications and Usage (34067-9)
Uses
Temporarily helps reduce discomfort from:
Minor burns, Insect bites, Minor skin irritations, Post-shaving or grooming sensitivity
External itching or rash due to dry skin
Dosage and Administration (34068-7)
Adults and children over 12 years:
Apply a thin layer to affected area
not more than 3-4 times daily
Children under 12 years: Consult a doctor before use
Wash hands after application
Warnings and Precautions (34071-1)
Warnings (For external use only)
For external use only
Do not use on large areas of the body or on broken, blistered, or abraded skin
Avoid contact with eyes, mouth and mucous membranes
If pregnant or breast feeding, consult a healthcare provider before use
Section 50565-1 (50565-1)
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
Stop use and ask a doctor if:
Condition worsens or symptoms persist for more than 7 days
Skin irritation, rash, or allergic reaction occurs
Section 51727-6 (51727-6)
Inactive ingredients
Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E), Carbomer, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose ............External analgesic
Section 55106-9 (55106-9)
Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic
Section 60561-8 (60561-8)
Store at room temperature (15-30°C/59-86'F)
Tamper evident: Do not use if seal is broken or missing
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:06:45.503871 · Updated: 2026-03-14T23:09:42.602872