CRYOMAX COOLING- menthol gel

Cryomax Cooling by

Drug Labeling and Warnings

Cryomax Cooling by is a Otc medication manufactured, distributed, or labeled by LIFE WEAR TECHNOLOGIES, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 9.5%

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.

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

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CRYOMAX COOLING 
menthol gel

Product 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)