Active Ingredient
Menthol 1.00%
Keracare Gel
FDA Label NDC 63766-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avlon Industries, Inc. for the product Keracare (NDC 63766-001). 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, 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
Topical analgesic
Use
for the temporary relief of itching associated with minor skin irritations of the scalp.
Warnings
for external use only
When Using This Product
avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor If
condition worsens, or if symptoms persist for 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
Adults: Apply to scalp at least twice per week. Use daily for maximum results. Children:Consult a physician.
Inactive Ingredients
Petrolatum, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Paraffin, Polyethylene, Salicylic Acid, Tocopheryl Acetate, Fragrance/Parfum, BHT, Sulfur, Butylphenyl Methylpropional, Alpha-Isomethyl Ionone, Amyl Cinnamal, Benzyl Salicylate, Cinnamyl Alcohol, Eugenol, Geraniol, Hydroxycitronellal, Isoeugenol, Limonene, Linalool, CI 26100.
Package Label.Principal Display Panel
63766-001-01
110g
63766-001-02
200g
* Please review the disclaimer below.
