pramoxine hydrochloride and zinc acetate lotion

FDA Drug Profile — TopCare Calaclear, Rugby Caldyphen Clear

Drug Details

Generic Name
pramoxine hydrochloride and zinc acetate lotion
Brand Names
TopCare Calaclear, Rugby Caldyphen Clear
Application Number
M016
Sponsor
TOPCO ASSOCIATES LLC
NDC Codes
2
Dosage Forms
LOTION
Routes
TOPICAL
Active Ingredients
PRAMOXINE HYDROCHLORIDE, ZINC ACETATE

Indications and Usage

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

For external use only. Use only as directed. Acoid contact with eyes and mucous membranes Ask a doctor before using on children under 2 years of age.