Active Ingredients
Calamine 8% and Zinc Oxide 8%
Calamine Lotion
FDA Label NDC 49035-413
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Calamine (NDC 49035-413). 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, when using this product, 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
Uses
dries the oozing and weeping of poison ivy, poison oak, and poison sumac.
Warnings
For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
Ask a doctor before using on children under 2 years of age.
When Using This Product
Discontinue use if condition worsens or does not improve within 7 days and consult a doctor.
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 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry before 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.
Other Information
Store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
Avicel, Bentonite magma, Calcium Hydroxide, Carrageenan, Glycerin, Purified Water, and Xanthan Gum.
Label
Principal Display Panel
NDC 49035-413-96
equate
Calamine
LOTION
(Calamine topical
suspension, USP)
6 FL OZ (177mL)
Revised: 12/2017 Wal-Mart Stores, Inc.
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