Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride

FDA Drug Profile — Caladryl

Drug Details

Generic Name
Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride
Brand Names
Caladryl
Application Number
M014
Sponsor
Bausch Health US, LLC
NDC Codes
1
Dosage Forms
LOTION
Routes
TOPICAL
Active Ingredients
FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE

Indications and Usage

Uses temporarily relieves pain and itching associated with: rashes due to poison ivy, poison oak or poison sumac insect bites minor skin irritation minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

Warnings For external use only. When using this product do not get into eyes 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.