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.
TOPICAL
PAIN RELIEF methyl salicylate, menthol, capsaicin cream | ||||||||||||||||||||||||||||||
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Labeler — Two Hip Consulting, LLC (965352896) |
Registrant — Two Hip Consulting, LLC (965352896) |
Revised: 02/2019 Two Hip Consulting, LLC
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https://otclabels.com/lib/otc/otc-meds/topical-pain-relief-5/