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Product NDC Code | 71207-461 | ||||
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Drug Name | Cryomax cooling |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | M017 | ||||
Labeler Name | LIFE WEAR TECHNOLOGIES | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol 9.5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Cryomax Cooling Menthol HORSE CHESTNUT ALCOHOL FD&C BLUE NO. 1 CARBOMER 940 CENTELLA ASIATICA LEAF MENTHOL, (+)- MENTHOL CAMPHOR OIL EUCALYPTUS OIL METHYL SALICYLATE GLYCERIN WATER HEDERA HELIX LEAF MELALEUCA CAJUPUTI LEAF OIL POLYGLYCERYL-4 CAPRATE RUSCUS ACULEATUS ROOT SODIUM HYDROXIDE FD&C YELLOW NO. 5 PEPPERMINT OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If swallowed, get medical help or contact a Poison Control Center right away.
Pregnancy or breast feeding
Pregnancy or Breast feedingAsk a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API