Active Ingredient
Lidocaine 4% ---Topical anesthetic
Topical Cream
FDA Label NDC 85284-002
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 Topical Cream (NDC 85284-002). 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, do not use:, directions, inactive ingredients, other information, 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,linor skin irritations,Post-shaving or grooming
sensitivity,External itching or rash due to dry skin
Warnings
For external use only
Do Not Use:
In or near eyes
▪ On large areas of the body or on broken, blistered, or abraded skin
▪ If allergic to local anesthetics such as lidocaine
When using this product:
▪ Avoid contact with eyes
▪ Do not bandage tightly or use with heating pad
▪ Keep out of reach of children
Stop use and ask a doctor if:
▪ Condition worsens or symptoms persist more than 7 days
Redness, rash, or irritation develops
▪ 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
85284-002-01 (Black)
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