TIDL SPORT CRYOTHERAPY JOINT MUSCLE- tidl sport cryotherapy joint muscle cream 
ANTHOS GROUP, INC, THE

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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79740-008
TIDL Sport Cryotherapy Joint & Muscle Cream

Active Ingredient(s)

Menthol 2%

Purpose

Topical Analgesic

Use

Temporary relief from minor aches and pains of muscles and joints associated with arthritis simple backache strains and sprains

Warnings

Warnings For external use only.

Do not use

do not use with heating pad or device.

Stop use and ask a doctor if

condition worsens , or if symptoms persist for more than 7 days or clear up and reoccur again within a few days.

When using this product

avoid contact with the eyes or mucous membranes.

do not apply to wounds or damaged skin.

do not apply to the irritated skin .

do not bandage.

wash hands after use with cool water .

do not use with heating pad or device.

If accidentally ingested get medical help or contact a Poison Control Center immediately

Directions

Adults and children 12 years of age and older: Apply to affected area not more than3 to 4 times daily.

Children under 12 years of age : Consult physician.

Other information

/

Inactive ingredients

Purified Water, Propylene Glycol USP, Organic Aloe Vera Juice, Isopropyl Myristate, Ceteareth 20, Methyl Salicylate, Eucalyptus Oil, Wintergreen Oil, Camphor Oil, Clove Bud, Beta-Caryophyllene(Clove), Glyceryl Stearate, Phenoxyethanol, Caprylyl Glycol, Ethyloxiglycerin, Disodium EDTA, Capsaicin, Organic Azulene, Carbomer, Aminomethyl Propanol

Package Label - Principal Display Panel

79740-008-0179740-008-02

TIDL SPORT CRYOTHERAPY JOINT MUSCLE 
tidl sport cryotherapy joint muscle cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79740-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
1,2-PROPANEDIOL, 1-BENZOATE (UNII: K4K90ZQ89N)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
WATER (UNII: 059QF0KO0R)  
CLOVE (UNII: K48IKT5321)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAMPHOR LEAF OIL (UNII: 51D0RGY52V)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CAPSAICIN (UNII: S07O44R1ZM)  
AZULENE (UNII: 82R6M9MGLP)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79740-008-0190 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2022
2NDC:79740-008-0290 mL in 1 BOX; Type 0: Not a Combination Product01/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/20/2022
Labeler - ANTHOS GROUP, INC, THE (117511051)
Establishment
NameAddressID/FEIBusiness Operations
ANTHOS GROUP, INC, THE117511051manufacture(79740-008)

Revised: 1/2022
 
ANTHOS GROUP, INC, THE