OTC Medication Information: Topical Pain Relief

TOPICAL PAIN RELIEF- methyl salicylate, menthol and 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.

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
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BACK
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 20 g in 100 g
MENTHOL (MENTHOL) MENTHOL 5 g in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN .0355 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
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 Code Package Description Multilevel Packaging
1 NDC:76074-120-01 120 g in 1 BOTTLE None
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)

Revised: 02/2019 Two Hip Consulting, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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