GENORTHIX PAIN RELIEVING ROLL ON- methyl salicylate, menthol, capsaicin solution

Genorthix Pain Relieving Roll On by

Drug Labeling and Warnings

Genorthix Pain Relieving Roll On by is a Otc medication manufactured, distributed, or labeled by Genorthix. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Methyl Salicylate 10.00%

Menthol 1.40%

Capsaicin 0.025%

Topical Analgesic

Uses

For the re lief of pain associated with arthritis, strains, sprains, bruises and backaches.

Warnings:

• For externa l use on ly.
• Avoid contact with eyes and mucous membranes.
• Do not bandage tight ly or cover treated areas.

Do not use

with heating pad.

• Do not app ly to open wounds or damaged skin.
• A mi ld burning sensation may occur. If severe burning sensation occurs, discontinue use immediate ly.
• If Symptoms persist for more than seven days, discontinue use and consu lt physician.

Keep out of reach of children.

If swallowed, consult physician.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

For adults:

App ly directly to effected area. Repeat as necessary, but do not use more than 3-4 times dai ly.

Other Ingredients:

Aqua (Deionized Water), Arnica Montana Flower Extract, Camphor, Carbomer, Ethy lhexylglycerin, G lycerrhiza G labra (Licorice) Extract, I-Arginine, I-G lutathione, Methy lsu lfony lmethane (MSM), Phenoxyethanol, Polysorbate-20, Salicy lic Acid, Triethanolamine, FD&C Blue #1, FD&C Ye llow #5.

Distributed by:

Genorthix.com Inc.

North Miami, Florida 33161

Www.Genorthix.com

Package Labeling:

INGREDIENTS AND APPEARANCE

GENORTHIX PAIN RELIEVING ROLL ON 
methyl salicylate, menthol, capsaicin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70248-708
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LICORICE (UNII: 61ZBX54883)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SALICYLIC ACID (UNII: O414PZ4LPZ)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70248-708-01	1 in 1 CARTON	02/08/2017
1		85 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/11/2015

Labeler - Genorthix (024942076)