FDA Label for Calamine
View Indications, Usage & Precautions
Calamine Product Label
The following document was submitted to the FDA by the labeler of this product 1201258 Ontario Inc. O/a Nanz Pharma. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Calamine 7.6% and Zinc Oxide 7.6%
Purpose
Skin protectant
Uses:
For temporary relief of skin irritations and itching caused by insect bites, sunburn, poison ivy, sumac, and poison oak.
Caution & Warnings:
For external use only.Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away. Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if symptoms worsen or last for more than 7 days.When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Do not use on broken skin.
Keep Out Of Reach Of Children
In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.
Directions
Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.
Children under 6 months of age: Consult a doctor before use.
Inactive Ingredients
Glycerin, Bentonite, Calcium Hydroxide, Water
Other Information:
Store at room temperature 13-30C (50-86F)
Package Label.Principal Display Panel
NDC: 83254-075
Labels for all sizes
* Please review the disclaimer below.