Active Ingredients
Calamine 8%
Zinc Oxide 8%
Health Care Calamine Lotion
FDA Label NDC 64092-413
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Great Lakes Wholesale, Marketing And Sales Inc for the product Health Care Calamine (NDC 64092-413). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Skin Protectant
Uses
Dries the oozing and weeping of poison ivy, poison oak, and poison sumac and other skin irritations.
Warnings
For external use only. Use only as directed.
Avoid contat with eyes and moucous membranes.
Ask A Doctor
before using on children under 6 years of age.
Stop use and ask a doctor if
- Condition worsens
- Symptoms last for more than 7 days or clear up and occur again within a few days.
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
Adults and children 6 mo. of age and older: Shake well before using. Cleanse the skin with soap and water. Let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort.
Children under 6 mo. of age: Consult a doctor before use.
Other Information
Store at room temperature 15-30C (59-86F)
Inactive Ingredients
Bentonite Magma, Calcium Hydroxide, Glycerin, and Purified Water.
* Please review the disclaimer below.
