ZINC OXIDE, CALAMINE

FDA Drug Profile — BABY ANTI MONKEY BUTT DIAPER RASH

Drug Details

Generic Name
ZINC OXIDE, CALAMINE
Brand Names
BABY ANTI MONKEY BUTT DIAPER RASH
Application Number
M016
Sponsor
Clarion Brands, LLC
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
FERRIC OXIDE RED, ZINC OXIDE

Indications and Usage

Uses for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

Warnings For external use only. Avoid contact with the eyes Not for Pediatric use Hypersensitivity to "caine" anesthetics Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth. Ask a doctor before use on chicken pox on measles Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days