Otc - Active Ingredient
Active ingredient
Menthol 10.5%
The following Structured Product Label (SPL) was submitted to the FDA by Carlin Consumer Health Llc for the product Mineral Ice Extreme Menthol Pain Relief (NDC 82632-252). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
Menthol 10.5%
Purpose
Topical analgesic
Uses • temporarily relieves minor aches and pains of muscles and joitns associated with:• simple backache • strains • bruises • sprains
Warning
For external use only
WARNING Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 50°C (120°F). Keep out of reach of children. WARNING Flammable. Keep away fro mfire or flame.
Do not use • with other topical pain relievers
• with heating pads or heating devices
When using this product • Avoid contact with eyes
• do not apply to wounds or damaged skin • do not bandage tightly
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
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions • clean affected area before applying product
• hold can and press nozzle lightly
• apply directly to targeted area
• wipe nozzle clean after each use • replace the overcape after each use
• adults and children 12 years of age and older: spray over affected area not more than 3 to 4 times daily
• children under 12 years of age: consult a physician
• storea at 20°-25°C (68°-77°F) • do not store at temperatures above 50°C (120°F)
Inactive ingredientsAlcohol Denat., Fragrance, Isopropyl Myristate, Methylsulfonymethane, Water
Questions? call 1-844-451-1653
@2026 CARLIN CONSUMER HEALTH, LLC
Distributed by: Carlin Consumer Health, LLC
Westport, CT 06880
MineralIceeXtreme.com
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