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 Preferred Pharmaceuticals Inc.. 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
Questions Or Comments?
(800) 616-2471
Adverse Reactions
Distributed By:
MAJOR PHARMACEUTICALS
17177 N LAUREL PARK DRIVE, SUITE 233
Livonia, MI 48152
Re-Order No 014282 M-97
Rev. 10/16
063.001/063AA
Relabeled By: Preferred Pharmaceuticals Inc.
Principal Display Panel
NDC 68788-0902-1
MAJOR
Relabeled By: Preferred Pharmaceuticals Inc.
Calamine
Lotion
Calamine Topical Suspension USP
Skin Protectant
Poison Ivy, Oak, Sumac
Drying Lotion
Shake well before using
6 FL OZ (177 mL)
* Please review the disclaimer below.