zinc oxide lotion

FDA Drug Profile — Leader Calamine Plus

Drug Details

Generic Name
zinc oxide lotion
Brand Names
Leader Calamine Plus
Application Number
M016
Sponsor
Cardinal Health, 110 dba Leader
NDC Codes
1
Dosage Forms
LOTION
Routes
TOPICAL
Active Ingredients
PRAMOXINE HYDROCHLORIDE, ZINC OXIDE

Indications and Usage

Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging causes by the sun

Warnings

Warnings For external use only Do not use on damanged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.