Sunmark Phenolated Calamine

Sunmark Phenolated Calamine is an FDA drug label for the active ingredient CALAMINE AND ZINC OXIDE AND PHENOL manufactured by Strategic Sourcing Services LLC 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 20231219.

Generic: CALAMINE AND ZINC OXIDE AND PHENOL

Manufacturer: Strategic Sourcing Services LLC

Product Type: HUMAN OTC DRUG

Route: TOPICAL

Dosage Form:

NDC: 49348-802

Application: M016

Effective: 20231219

Active Ingredients: Active Ingredient Calamine 8%Active Ingredient Zinc Oxide 8%Active Ingredient Liquefied Phenol

Indications & Usage

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

Dosage & Administration

directions (Shake well before using) Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 2 years of age : Consult a doctor before use.

Contraindications

Not available.

Warnings

Warnings For external use only . Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas. If applied to fingers or toes do not bandage.

Adverse Reactions