Pramoxine Hydrochloride and Menthol

FDA Drug Profile — Anti Itch Maximum Relief

Drug Details

Generic Name
Pramoxine Hydrochloride and Menthol
Brand Names
Anti Itch Maximum Relief
Application Number
M017
Sponsor
Natureplex LLC
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
MENTHOL, UNSPECIFIED FORM, PRAMOXINE HYDROCHLORIDE

Indications and Usage

Use For temporary relief of pain and itching associated with minor skin irritations, minor burns, minor cuts, sunburns, scrapes, insect bites, and rashes due to poison ivy, poison oak, or poison sumac

Warnings

Warnings For external use only. Avoid contact with eyes and nose. Not for prolonged use. Do not use on large areas of the body Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness, irritation, swelling, or pain develops, persists, or increases If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.