EXOTEN-C - methyl salicylate, menthol and capsaicin lotion
MedChem Manufacturing 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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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

76420-094401

EXOTEN-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

EXOTEN-C
methyl salicylate, menthol, capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76420-944
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methyl salicylate (Methyl salicylate)	Methyl salicylate	20 g in 100 g
Menthol (Menthol)	Menthol	10 g in 100 g
Capsaicin (Capsaicin)	Capsaicin	0.002 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water
Ethylhexyl Palmitate
CETOSTEARYL ALCOHOL
Glycerin
ARNICA MONTANA
Aloe Vera Leaf
ALPHA-TOCOPHEROL ACETATE
TROLAMINE
Phenoxyethanol
METHYLDIBROMO GLUTARONITRILE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:76420-944-01	113.4 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	05/08/2012

Labeler - MedChem Manufacturing Inc. (059888437)

Revised: 05/2012 MedChem Manufacturing Inc.