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 Pharma Nobis, Llc. 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.
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Drug Facts
Active Ingredients
Calamine 8% and Zinc Oxide 8%
Uses
Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.
Purpose
Skin protectant
Warnings
For external use only. Use only as directed.
Avoid contact with eyes and mucous membranes.
Ask a doctor before using on chilren under 2 years of age.
Stop Use And Ask A Doctor If
condition worsens, does not improve or if symptoms last 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 (1-800-222-1222) right away.
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, not more than 3 to 4 times daily as needed for comfort.
Children under 2 years of age: Consult a doctor before use
Other Information
Store at room temperature 15-30C (59-86F)
Inactive Ingredients
Avicel, Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water, and Xanthan Gum
Questions
Questions or Comments? 1-833-551-0932
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