Label: CRYOMAX COOLING- menthol gel
- NDC Code(s): 71207-461-03
- Packager: LIFE WEAR TECHNOLOGIES
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 13, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
- PREGNANCY OR BREAST FEEDING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CRYOMAX COOLING
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71207-461 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, (+)- 9.5 g in 100 g Inactive Ingredients Ingredient Name Strength HORSE CHESTNUT (UNII: 3C18L6RJAZ) ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CARBOMER 940 (UNII: 4Q93RCW27E) CENTELLA ASIATICA LEAF (UNII: 6810070TYD) CAMPHOR OIL (UNII: 75IZZ8Y727) EUCALYPTUS OIL (UNII: 2R04ONI662) METHYL SALICYLATE (UNII: LAV5U5022Y) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) HEDERA HELIX LEAF (UNII: ZP9XFG71A7) MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885) RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q) SODIUM HYDROXIDE (UNII: 55X04QC32I) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71207-461-03 99 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/01/2023 Labeler - LIFE WEAR TECHNOLOGIES (131710969) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(71207-461)
