FDA Label for Topical Cream
View Indications, Usage & Precautions
Topical 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.
Active Ingredient
Lidocaine 4% ---Topical anesthetic
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
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