FDA Label for Numbing Cream
View Indications, Usage & Precautions
Numbing Cream Product Label
The following document was submitted to the FDA by the labeler of this product Bloomwell Gardens Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic
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.
