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

Dries the oozing and weeping and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.

Warnings

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on children under 2 years of age. When using this product. Discontinue use if condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.