Otc - Active Ingredient
Active ingredient
Menthol 10%
Mineral Ice Extreme Gel
FDA Label NDC 82632-253
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Carlin Consumer Health Llc for the product Mineral Ice Extreme Gel (NDC 82632-253). 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.
Label Section Quick Index
Otc - Purpose
Purpose
Topical analgesic
Indications & Usage
Uses
• temporarily relieves minor aches and pains of muscles and joints associated with:
• simple backache • strains • bruises • sprains
Warnings
Warnings
For external use only
Flammable: Keep away from excessive heat or open flame
Otc - Do Not Use
Do not use
- with other topical pain relievers
- with heating pads or heating devices
Otc - When Using
When using this product
- avoid contact with eyes
- do not apply to wounds or damaged skin
- do not bandge tightly
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Dosage & Administration
Directions
- adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: do not use, consult a doctor
Other Information
- store at 20°-25°C (68°-77°F), in a tightly closed container
- Flammable: Keep away from excessive heat or open flame
Inactive Ingredient
Inactive ingredients Alcohol Denat., Aqua (Water), Propylene Glycol, Polyacrylate Crosspolymer-6, Acrylates/C10-30 Alkyl Acrylate Crosspolyer, Aminomethyl Propanol, Ethylhexylglycerin, Lysine, Copper Sulfate, Manganese Chloride, Aluminum Chloride, Gluconolactone, Magnesium Chloride, Potassium Chloride, Phenethyl Alcohol, Sodium Benzoate, Zinc Chloride, Caprylyl Glycol, Calcium Gluconate, Fragrance (Parfum), Phenoxyethanol, Sodium Chloride
Otc - Questions
Questions or comments? call 1-844-451-1653
Other
@2026 CARLIN CONSUMER HEALTH, LLC
Distributed by:
Carlin Consumer Health, LLC
Westport, CT 06880
MADE IN CANADA
MineralIceXtreme.com
Package Label.Principal Display Panel
Mineral
Ice ®
EXTREME ™
WITH DEEPCOLD ®
ICE MENTHOL
MENTHOL
PAIN
RELIEF
GEL
ALPINE FRESH ™ SCENT
4 FL OZ (118 mL)
* Please review the disclaimer below.
