Active Ingredient
Ferric Oxide Red 80 mg in 1 mL
Zinc Oxide 80 mg in 1 mL
Calamine Lotion
FDA Label NDC 87541-435
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marie's Original Formulas Llc for the product Calamine (NDC 87541-435). 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, when using this product, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Uses
Temporarily relieves itching associated with:
• poison ivy
• poison oak
• poison sumac
• insect bites
• minor skin irritations
Helps dry the oozing and weeping caused by poison ivy, poison oak, and poison sumac.
Temporarily protects irritated skin.
When Using This Product
Avoid contact with eyes.
Condition worsens.
Symptoms last more than 7 days.
Symptoms 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 use.
Adults and children 2 years of age and older:
Apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age:
Ask a doctor.
Other Information
Store at 20°–25°C (68°–77°F).
Protect from freezing.
Inactive Ingredients
Water
Bentonite Magma
Calcium Hydroxide Solution
Glycerin
Questions Or Comments?
Call 1-888-48-MARIE
Warnings
For external use only.
Principal Display Panel
Calamine Lotion
Calamine Topical Suspension USP
Skin Protectant
Poison Ivy, Oak and Sumac Drying Lotion
Relieves Itching
Helps Dry Oozing and Weeping
Protects and Soothes Irritated Skin
Shake Well
For External Use Only
Net Contents 6 fl oz (177 mL)
* Please review the disclaimer below.
