Otc - Active Ingredient
Menthol 9.5%
Cryomax Cooling Gel
FDA Label NDC 71207-461
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Life Wear Technologies for the product Cryomax Cooling (NDC 71207-461). 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 - keep out of reach of children, dosage & administration, inactive ingredient, 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
Topical Analgesic
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only.
When using this product avoid contact with eyes. Use only as directed. Do not bandage tightly or use with heating pad. Do not apply to wounds or damaged skin.
Flammable: keep away from fire or flame.
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, redness is present, excessive irritation of the skin develops.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- 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: consult a physician. Clean the affected area. Shake the airless bottle and squeeze a small amount of the cooling foam gel onto hand and apply it to the affected area. Repeat as necessary.
Inactive Ingredient
Aesculus Hippocastanum (Horse Chestnut) Leaf Extract, Alcohol Denat., Blue 1, Carbomer, Centella Asiatica Extract, Cinnamomum (Camphor) Bark Oil, Eucalyptus Globulus Leaf Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Hedera Helix (Ivy) Leaf Extract, Melaleuca Leucadendron Cajoput Oil, Mentha Piperita (Peppermint) Oil, Polyglyceeryl-4 Caprate, Ruscus Aculeatus Root Extract, Sodium Hydroxide, Water, Yellow 5
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
* Please review the disclaimer below.
