PAIN RELIEFROLL ON ROLL ON- methyl salicylate mentol camphor capsaicin liquid

Pain ReliefRoll On by

Drug Labeling and Warnings

Pain ReliefRoll On by is a Otc medication manufactured, distributed, or labeled by Creations Garden Natural Products, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Methyl Salicylate 30% .......….......… Topical Analgesic
Menthol 10% ...……......……….....… Topical Analgesic
Camphor 4% .……..…….............….. Topical Analgesic
Capsaicin 0.03% .……..…….............Topical Analgesic

Uses

■ Temporarily relieves the minor aches and pains of
muscles and joints associated with: ■ arthritis
■ strains ■ bruises ■ sprains ■ backache

Warnings

For external use only

Do not use: ■ on wounds or damaged skin
■ with a heating pad ■ on a child under 12 years of
age with arthritis like conditions

Directions

Directions
■ Use only as directed
■ Adults and children 12 years of age and older apply
to affected area not more than 3 to 4 times daily
■ Children under 12 years of age ask a doctor

Inactive ingredients

Inactive ingredients
Water, PEG-8, Sodium Polyacrylate (and) Dimethicone (and) Cyclopentasiloxane (and) Trideceth-6 (and) PEG/PPG-18 Dimethicone, Glucosamine Hydrochloride, Petrolatum, Propylene Glycol, Beeswax, MSM, Phenoxyethanol

Questions?

Questions? Call 1-305-785-6161

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEFROLL ON   ROLL ON
methyl salicylate mentol camphor capsaicin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y)	Methyl Salicylate	21 g  in 70 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	7 g  in 70 g
CAMPHOR, (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR, (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR, (SYNTHETIC)	2.8 g  in 70 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Glucosamine Hydrochloride (UNII: 750W5330FY)
Petrolatum (UNII: 4T6H12BN9U)
Propylene Glycol (UNII: 6DC9Q167V3)
Wax, Yellow (UNII: 2ZA36H0S2V)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
Phenoxyethanol (UNII: HIE492ZZ3T)
Capsaicin (UNII: S07O44R1ZM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-002-33	70 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/10/2010

Labeler - Creations Garden Natural Products, Inc. (839471216)

Registrant - Creations Garden Natural Products, Inc. (839471216)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products, Inc.		839471216	manufacture