TOPICAL PAIN RELIEF- methyl salicylate, menthol, capsaicin cream

Topical by

Drug Labeling and Warnings

Topical by is a Otc medication manufactured, distributed, or labeled by Two Hip Consulting, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Methyl salicylate 20% (16gm)

Menthol 5% (4 gm)

Capsaicin 0.035% (0.3gm)

PURPOSE

TOPICAL ANALGESIC

USES

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness. This product does not cure any diseases.

WARNINGS

Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor.

Discontinue use and consult a physician if condition worsens or irritation develops. Pain persists for more than 7 days. If pain clears up and then redevelops.

Do not use: on cuts or infected skin, on children less than 12 years old, in combination with other topical pain products, if allergic to any ingredients, PABA, aspirin products, or sulfa. Do not use if you are pregnant or nursing. Store below 90 degrees F/32 degrees C. See USP Controlled Temperature.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

Inactive Ingredients

Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, sodium Hydroxide, Stearyl Alcohol, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPICAL  PAIN RELIEF
methyl salicylate, menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76074-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.0355 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76074-120-01	120 g in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/15/2011

Labeler - Two Hip Consulting, LLC (965352896)

Registrant - Two Hip Consulting, LLC (965352896)