Active Ingredients
Calamine 8%
Zinc oxide 8%
Calamine Lotion
FDA Label NDC 55319-063
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Stores, Inc for the product Calamine (NDC 55319-063). 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 ingredients, 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
Other
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320
Not 100% satisfied?
Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.
Principal Display Panel
FAMILY WELNESS
Calamine Lotion
SKIN PROTECTANT
Calamine Topical Suspension USP
Drying Lotion Treats Poison Ivy,
Poison Oak, and Poison Sumac
100% SATISFACTION GUARANTEED
OR YOUR MONEY BACK
6 FL OZ (177 mL)
Image Description (Mm3)
* Please review the disclaimer below.
