TOPICAL PAIN RELIEF- methyl salicylate, menthol, capsaicin cream 
Two Hip Consulting, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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.

FRONT

BACK

TOPICAL  PAIN RELIEF
methyl salicylate, menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76074-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.0355 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76074-120-01120 g in 1 BOTTLE; Type 0: Not a Combination Product01/15/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/2011
Labeler - Two Hip Consulting, LLC (965352896)
Registrant - Two Hip Consulting, LLC (965352896)

Revised: 2/2019
Document Id: 7dab642c-d408-4e2c-8fcd-6a187d70f9e7
Set id: 1ead4bb2-fee5-47d5-8a16-3043a498799d
Version: 7
Effective Time: 20190208
 
Two Hip Consulting, LLC