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EXOTEN-C by Asclemed USA, Inc.

Medically reviewed on May 16, 2018

Dosage form: lotion
Ingredients: Methyl salicylate 20g in 100g, Menthol 10g in 100g, Capsaicin 0.002g in 100g
Labeler: Asclemed USA, Inc.
NDC Code: 76420-944

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.

Drug Facts

Active ingredients

Methyl salicylate 20%

Menthol USP 10%

Capsaicin 0.002%

Purpose

Topical analgesic

Use

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • sprains
  • strains
  • bruises

Warnings

For external use only.

Do not use
  • on wounds
  • damaged, broken, or irritated skin
  • with a heating pad
  • immediately before or after taking a bath or shower

Stop use and ask a doctor if
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • skin irritation occurs

When using this product
  • avoid contact with lips, eyes, nose and any mucous membranes at all times
  • do not bandage tightly

Keep out of reach of children.

If swallowed get medical help or contact Poison Control Center right away.

Directions
  • use only as directed
  • Wash hands thoroughly after use to avoid spreading lotion to the eyes or other sensitive areas of the body
  • if applying lotion to the hands, wait 30 minutes before washing hands
  • Adults and children 12 years of age and older:
    • apply to affected area not more than 3-4 times daily
  • Children under 12 years of age:
    • do not use
    • consult a doctor

Other information
  • Store at room temperature

Inactive ingredients

D.I. Water, Ethylhexyl Palmitate, Cetearyl Alcohol, Glycerin, Arnica Extract, Aloe Babadensis (Aloe Vera) Leaf Extract, Vitamin E Acetate, Carbomer, Triethanolamine, Phenoxyethanol and Methyldibrome Glutaronitrile

PRINCIPAL DISPLAY PANEL – BOTTLE LABEL

76420-944-01

EXOTEN-C

Pain Relief
Lotion

Beneficial for relieving
muscle pain and swelling

Manufactured for: Net Wt. 4 oz
Enovachem Pharmaceuticals (113.4 g)
Torrance, CA 90501

310-320-0100

EXOTEN-C 
methyl salicylate, menthol, capsaicin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-944
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methyl salicylate (Salicylic acid) Methyl salicylate20 g  in 100 g
Menthol (Menthol) Menthol10 g  in 100 g
Capsaicin (Capsaicin) Capsaicin0.002 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Ethylhexyl Palmitate 
CETOSTEARYL ALCOHOL 
Glycerin 
ARNICA MONTANA 
Aloe Vera Leaf 
ALPHA-TOCOPHEROL ACETATE 
TROLAMINE 
Phenoxyethanol 
METHYLDIBROMO GLUTARONITRILE 
Packaging
#Item CodePackage Description
1NDC:76420-944-01113.4 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/08/2012
Labeler - Asclemed USA, Inc. (059888437)

 
Asclemed USA, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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