Otc - Active Ingredient
Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic
Numbing Cream
FDA Label NDC 85284-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bloomwell Gardens Llc for the product Numbing Cream (NDC 85284-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive ingredients
Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E), Carbomer, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin
Otc - Purpose
Purpose ............External analgesic
Indications & 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
Warnings
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
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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & 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
Other Safety Information
Store at room temperature (15-30°C/59-86'F)
Tamper evident: Do not use if seal is broken or missing
* Please review the disclaimer below.
