MEDISTIK COOLING ROLL-ON- menthol, camphor solution

MEDISTIK COOLING ROLL-ON by

Drug Labeling and Warnings

MEDISTIK COOLING ROLL-ON by is a Otc medication manufactured, distributed, or labeled by Medistik Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Menthol 10%

Camphor 4%

PURPOSE

Topical Analgesic

USES

For the temporary relief of sore muscles and joints associated with

• simple backache
• arthritis
• strains
• sprains
• bruises
• cramps

WARNINGS

When using this product

• use only as directed
• avoid getting into the eyes and mucous membranes
• do not bandage tightly or use with a heating pad
• do not apply to wounds or damaged skin

Stop use and ask doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• excessive skin irritation or redness occurs

If pregnant or breast-feeding, ask a health professional before use.

DIRECTIONS

• For use on adults and children over 12 years of age and older: Apply product on affected area, not more than 4 times daily
• children under 12 years of age: ask a doctor

INACTIVE INGREDIENTS

Denatured alcohol, Water, Peppermint oil, Glycerin, Polyacrylate Crosspolymer-6, MSM, Ilex paraguariensis leaf extract, Glucosamine sulphate, Chondroitin sulphate, Folic acid, Vitamin C, Vitamin D.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDISTIK COOLING ROLL-ON 
menthol, camphor solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77108-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 mL
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)
FOLIC ACID (UNII: 935E97BOY8)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
VITAMIN D (UNII: 9VU1KI44GP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77108-103-11	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/14/2020

Labeler - Medistik Inc (204132562)