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 Dzb Brands, 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.
Otc - Active Ingredient
Active ingredientsCalamine 8%Zinc Oxide 8%
Otc - Purpose
PurposeSkin protectant
Indications & Usage
Use dries the oozing and weeping of poison: • ivy • oak • sumac
Warnings
WarningsFor external use only
Otc - When Using
When using this product do not get into eyes
Otc - Stop Use
Stop use and ask a doctor if •condition worsens • symptoms last more than 7 days or clear up and occur again withing a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions• shake well before using• apply as needed
Storage And Handling
Other information store at 59⁰ - 86⁰F
Inactive Ingredient
Inactive ingredients bentonite magma, calcium hydroxide, glycerin, purified water
Adverse Reactions
Distributed by: DZA Brands, LLC2110 Executive DriveSalisbury, NC 28147For product questions or concernscontact us at 1-866-322-2439Please include the UPC number andcode from package
Package Label.Principal Display Panel
NDC 55316-063-26healthyaccentscalamine topical suspension USPcalamine lotinskin protectantpoison ivy, oak + sumacdrying lotion4 FL OZ (118 mL)
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