Numbing cream
3c404ff7-8b88-9f6b-e063-6294a90a2d91
HUMAN OTC DRUG LABEL
Aug 13, 2025
BLOOMWELL GARDENS LLC
DUNS: 124839891
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pramoxine Hydrochloride 1%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic
INACTIVE INGREDIENT SECTION
Inactive ingredients
Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E), Carbomer,
Propylene Glycol, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin
OTC - PURPOSE SECTION
Purpose ............External analgesic
WARNINGS SECTION
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
OTC - STOP USE SECTION
Stop use and ask a doctor if:
Condition worsens or symptoms persist for more than 7 days
Skin irritation, rash, or allergic reaction occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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
OTHER SAFETY INFORMATION
Store at room temperature (15-30°C/59-86'F)
Tamper evident: Do not use if seal is broken or missing