EXOTEN-C- methyl salicylate, menthol, capsaicin lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)

Available from:

Asclemed USA, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

EXOTEN-C- METHYL SALICYLATE, MENTHOL, CAPSAICIN LOTION
ASCLEMED USA, INC.
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DRUG FACTS
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
[phone]
EXOTEN-C
methyl salicylate, menthol, capsaicin lotion
Asclemed USA, Inc.
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:O414PZ 4LPZ )
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 (U