XOTEN-C - methyl salicylate, menthol, capsaicin lotion 
Living Well Pharmacy Inc.

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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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:

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

Other information

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

64038-094401

XOTEN-C

Pain Relief
Lotion

Beneficial for relieving
muscle pain and swelling

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

Principal Display Panel – Bottle Label
XOTEN-C 
methyl salicylate, menthol, capsaicin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64038-944
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methyl salicylate (UNII: LAV5U5022Y) (Methyl salicylate - UNII:LAV5U5022Y) Methyl salicylate20 g  in 100 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol10 g  in 100 g
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.002 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Ethylhexyl Palmitate (UNII: 2865993309)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Glycerin (UNII: PDC6A3C0OX)  
ARNICA MONTANA (UNII: O80TY208ZW)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64038-944-01113.4 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2011
Labeler - Living Well Pharmacy Inc. (070488957)

Revised: 7/2011
Document Id: 8f97fcd2-08db-4b14-95c6-898c22188a2f
Set id: 1dcb64fd-6bc6-4375-8d30-4462e2407934
Version: 1
Effective Time: 20110726
 
Living Well Pharmacy Inc.