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 Dolgencorp, 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 within a few days
Otc - Keep Out Of Reach Of Children
Keep out of the 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 - 86⁰ F
Inactive Ingredient
Inactive ingredients bentonite magma, calcium hydroxide, glycerin, purified water
Adverse Reactions
Visit us at: Rexall.comor call 1-866-4REXALLDISTRIBUTED BY DOLGENCORP, LLC100 MISSION RIDGEGOODLETTSVILLE, TN 37072 USA
Package Label.Principal Display Panel
Since 1903REXALLCalamine LotionCalamine topical Suspension USP• Poison ivy, oak and sumac drying lotion• Skin protectant6 FL OZ (177 mL)
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