Leader Calamine Plus

ZINC OXIDE LOTION TOPICAL HUMAN OTC DRUG

Leader Calamine Plus is an FDA drug label for the active ingredient ZINC OXIDE LOTION manufactured by Cardinal Health, 110 dba Leader administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231222.

Generic name
ZINC OXIDE LOTION
Manufacturer
Cardinal Health, 110 dba Leader
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
70000-0400
Application
M016
Label effective
20231222

Active ingredients

Calamine 8% Pramoxine HCl 1%

Indications & 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

Dosage & Administration

Adults and children 2 years of age and older: Shake well before using. CLeanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton of soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: Consult a doctor before use.

Warnings

For external use only Avoid contact with eyes and mucous membranes Ask a doctor before using on children under 2 years of age