CRYOFREEZE SPORT ICY COLD ROLL-ON- menthol, unspecified form gel

Cryofreeze Sport by

Drug Labeling and Warnings

Cryofreeze Sport by is a Otc medication manufactured, distributed, or labeled by Omax Health, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Natural Menthol, USP (8.5%)

Purpose

Topical Analgesic

Uses

Temporary relief from minor aches and pains from sore muscles and joints, backache, arthritis.

Warnings

For external use only.

Flammable: Keep out of reach of children.

Contact a doctor before using if you have sensitive skin, are pregnant, breastfeeding or on any medication. If swallowed get medical help or call Poison control center immediately.

Directions

Use only as directed. Do not use on children under 12 years of age. Roll onto affected area no more than four times daily.

When using this product

Do not use with heating pad. Do not bandage. Wash hands with cold water immediately after use and do not touch eyes or mucous membranes. Stop use and ask a doctor if redness or irritation occurs, if condition worsens, or if pain persists for more than 7 days or clears up, then reoccurs.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Extract, Beta-Caryophyllene, Boswellia Serrata Extract, Camphor, Carbomer, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis Extract, Isopropyl Alcohol, Magnesium Citrate, Methylsulfonylmethane (MSM), Peppermint Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Purified Water, Triethanolamine. No Parabens.

Other Information

Questions call 1-800-765-6691. Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, colors may vary.

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label

CRYOFREEZE™
SPORT

ICY COLD ROLL-ON

3 fl oz / 89 mL

INGREDIENTS AND APPEARANCE

CRYOFREEZE SPORT   ICY COLD ROLL-ON
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73036-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	85 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CARYOPHYLLENE (UNII: BHW853AU9H)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM CITRATE (UNII: RHO26O1T9V)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73036-002-01	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	10/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/20/2020

Labeler - Omax Health, Inc (965730778)