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 Better Living 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.

Active Ingredents



Calamine 8%
Zinc oxide 8%


Purpose



Skin Protectant


Use



dries the oozing and weeping of poison:•ivy • oak • sumac


Warnings



For external use only


When Using This Product



Do not get into eyes


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

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away


Directions



  • shake well before using
  • apply as needed

Other Information



store at 59⁰ - 86⁰ F


Inactive Ingredients



bentonite magma, calcium hydroxide, glycerin, purified water


Adverse Reaction



DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929 www.betterlivingbrandsLLC.com


Principal Display Panel



Signature Care Quality Guaranteed

Calamine Lotion

Calamine Topical Suspension U.S.P.

Skin Protectant

Poion Ivy, Oak, Sumac Drying Lotion

6 FL OZ (177 mL)

063.001/063AA


* Please review the disclaimer below.