EXOTEN-C- methyl salicylate, menthol, capsaicin lotion

EXOTEN-C by

Drug Labeling and Warnings

EXOTEN-C by is a Otc medication manufactured, distributed, or labeled by Asclemed USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

EXOTEN-C 
methyl salicylate, menthol, capsaicin lotion

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methyl salicylate (UNII: LAV5U5022Y) (Salicylic acid - UNII:O414PZ4LPZ)	Methyl salicylate	20 g  in 100 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	10 g  in 100 g
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.002 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76420-944-01	113.4 g in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/08/2012

Labeler - Asclemed USA, Inc. (059888437)