PLAYMAKAR ROLL ON COOL PAIN RELIEF- menthol gel

PlayMakar Roll On Cool Pain Relief by

Drug Labeling and Warnings

PlayMakar Roll On Cool Pain Relief by is a Otc medication manufactured, distributed, or labeled by PlayMakar Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Avoid contact with eyes
• If symptoms persist for more than seven days, discontinue use and consult physician.

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

• Adults and children two-years of age or older: Apply to affected area not more than three to four times dail
• Children under two-years of age: consult a physician

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:

INGREDIENTS AND APPEARANCE

PLAYMAKAR ROLL ON COOL PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72909-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72909-015-01	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/20/2019

Labeler - PlayMakar Inc. (079213529)