Active Ingredient
Calamine 8%,
Zinc Oxide 8%
Calamine Lotion
FDA Label NDC 70677-1316
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services for the product Calamine (NDC 70677-1316). 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 ingredient, purpose, uses, warnings, when using this product, ask a doctor before using, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Uses
Dries the oozing and weeping of poison:
- ivy
- oak
- sumac
Warnings
- For external use only
- Use only as directed.
When Using This Product
do not get into eyes
Ask A Doctor Before Using
on children under 2 years of age.
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.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- shake well before using
- cleanse the skin with soap and water
- let dry before each use
- apply lotion to the affected area using cotton or soft cloth
| adults and children 2 years and older | 3 to 4 times daily as needed for
comfort |
| children under 2 years | Consult a doctor before use |
Other Information
Store at room temperature 15°- 30°C (59° - 86°F)
Inactive Ingredients
bentonite magma, calcium hydroxide, carageenan, glycerin, microcrystalline cellulose, purified water and xanthan gum
Questions Or Comments?
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L0001217 Rev. 0126
Container Label
NDC 70677-1316-1
Foster & Thrive ®
Calamine
Lotion
Calamine 8%,
Zinc Oxide 8%
TOPICAL SUSPENSION, USP
SKIN PROTECTANT
Poison ivy, oak, & sumac
drying lotion
6 FL. OZ (177 mL)
Image001 (Image001)
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