Otc - Active Ingredient
Lidocaine 4% --- Topical Anesthetic
Numbing Cream Maximum Strength Cream
FDA Label NDC 85284-006
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 Maximum Strength (NDC 85284-006). 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, stop use and ask a doctor if:, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
