Active Ingredents
Calamine 8%
Zinc oxide 8%
Calamine Lotion
FDA Label NDC 0904-2533
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Calamine (NDC 0904-2533). 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 ingredents, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Principal Display Panel
NDC 0904-2533-21
MAJOR
Calamine
Lotion
Calamine Topical Suspension USP
Skin Protectant
Poison Ivy, Oak, Sumac
Drying Lotion
Shake well before using
6 FL OZ (177 mL)
Image Description (Mm1)
Image Description (Mm1)
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