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 20.000%

Menthol 10.00%

Capsaicin 0.025%

Purpose

Topical Analgesic

Topical Analgesic

Topical Analgesic

Indications

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings

For external use only. Avoid contact with eyes.

If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children. If swallowed, consult physician.

Do not apply to wounds or damaged skin. Do not bandage tightly.

If pregnant or breast feeding, contact physician prior to use.

Directions

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.

Children under two-years of age consult a physician.

Additional Information

Store at room temperature.

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice; Aqua (Deionized Water); Arnica Montana Flower Extract; Carbomer, Cetearyl Alcohol, Ethylexyl Palmitate, Glyceryl Stearate, Methylisothiazolinone, PEG-100 Stearate, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Principal Display Panel - Exoten-C Label

Exoten-C

Pain Relief 
Lotion

113.4 g

Distributed by Enovachem™

PHARMACEUTICALS

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: 76420-947
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	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76420-947-01	113.4 g in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/10/2017

Labeler - Asclemed USA, Inc. (059888437)