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Topical Pain Relief by Unit Dose Services

Medically reviewed on December 6, 2017

Dosage form: cream
Ingredients: METHYL SALICYLATE 20g in 100g, MENTHOL 5g in 100g, CAPSAICIN .0355g in 100g
Labeler: Unit Dose Services
NDC Code: 50436-9990

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.

Topical Pain Relief

Active ingredients                               Purpose Methyl salicylate 20% (16gm)            Topical Analgesic Menthol 5% (4gm)                             Topical Analgesic Capsaicin 0.035% (0.3gm)                 Topical Analgesic









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.


Keep out of reach of children

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.

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.



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.


TOPICAL PAIN RELIEF (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM
TOPICAL   PAIN RELIEF
methyl salicylate, menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-9990(NDC:76074-120)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE20 g  in 100 g
MENTHOL (MENTHOL) MENTHOL5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN.0355 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
FD&C GREEN NO. 3 
HYPROMELLOSE 2208 (100000 MPA.S) 
ISOPROPYL PALMITATE 
METHYLISOTHIAZOLINONE 
PHENOXYETHANOL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
SODIUM HYDROXIDE 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:50436-9990-1120 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/2011
Labeler - Unit Dose Services (831995316)
Registrant - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIOperations
Unit Dose Services831995316REPACK(50436-9990)

 
Unit Dose Services

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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