Active Ingredient
Lidocaine 4% ---Topical anesthetic
Numbing Cream
FDA Label NDC 85284-003
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 85284-003). 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 active ingredient, purpose, uses, warnings, stop use and ask a doctor if:, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local anesthetic
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
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 symptomspersist for more than 7 days.
Skin irritation, rash, or allergic reaction occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
▪ 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
Inactive Ingredients
Purified Water, Glycerin, Allantoin,Tocopheryl Acetate (Vitamin E),Carbomer, Propylene Glycol,Sodium Hydroxide, Phenoxyethanol,
Ethylhexylglycerin
Other Information
Store at room temperature (15–30°C / 59–86°F) Tamper evident: Do not use if seal is broken or missing.
Principal Display Panel
85284-003-01 (Blue)
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