FDA Label for Numbing Cream Maximum Strength
View Indications, Usage & Precautions
Numbing Cream Maximum Strength 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
Lidocaine 4% --- Topical Anesthetic
Inactive Ingredient
Purified Water, Glycerin, Allantoin, Tocopheryl Acetate
(Vitamin E), Carbomer,Propylene Glycol,
Sodium Hydroxide, Phenoxyetha-nol, Ethylhexylglycerin
Otc - Purpose
Local anesthetic
Indications & Usage
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
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 breastfeeding,consult a healthcare provider
before 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
Other Safety Information
Tamper evident: Do not use if seal is broken or missing.
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
* Please review the disclaimer below.
