PLAYMAKAR ROLL ON COOL PAIN RELIEF- menthol gel 
PlayMakar Inc.

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PlayMakar Roll-On Cool Pain Relief Gel

Drug Facts

Active ingredient

Menthol 6%

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises, and strains.

Warnings

For external use only

Keep out of reach of children

If swallowed, consult physician

Do not apply

  • to wounds or damaged skin
  • Do not bandage tightly

If pregnant or breast feeding

contact physician prior to use

Directions

Other information

store at room temperature

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctium Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Phenoxyethanol, Polysorbate- 20,  Tocopheryl Acetate (Vitamin E), Triethanolamine

Package Labeling:

UL2023

PLAYMAKAR ROLL ON COOL PAIN RELIEF 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72909-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA (UNII: O80TY208ZW)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MELISSA OFFICINALIS (UNII: YF70189L0N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72909-015-0188 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/20/2019
Labeler - PlayMakar Inc. (079213529)

Revised: 11/2023
Document Id: 0974b923-d026-7dcc-e063-6294a90aeb1b
Set id: a12c16e7-561f-45a7-93c6-34d693ffdc7c
Version: 4
Effective Time: 20231105
 
PlayMakar Inc.