Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (20 g) Menthol (10 g) Capsaicin (0.025 g)

Inactive Ingredients

Aloe Vera Leaf Water Arnica Montana Flower Cetostearyl Alcohol Ethylhexyl Palmitate Glyceryl Stearate Se Methylisothiazolinone Peg-100 Stearate .alpha.-tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-02-10

Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 20.000% Menthol 10.00% Capsaicin 0.025%

Section 50565-1

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

Section 50569-3

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

Section 50570-1

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

Section 53414-9

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

Warnings

For external use only. Avoid contact with eyes.

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.

Indications

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

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.

Active Ingredients

Methyl Salicylate 20.000%

Menthol 10.00%

Capsaicin 0.025%

Additional Information

Store at room temperature.

Principal Display Panel Exoten C Label

Exoten-C

Pain Relief  Lotion

113.4 g

Distributed by Enovachem™

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

Structured Label Content

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

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

Purpose

Topical Analgesic

Warnings

For external use only. Avoid contact with eyes.

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.

Indications

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

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.

Active Ingredients

Methyl Salicylate 20.000%

Menthol 10.00%

Capsaicin 0.025%

Additional Information

Store at room temperature.

Principal Display Panel Exoten C Label (Principal Display Panel - Exoten-C Label)

Exoten-C

Pain Relief  Lotion

113.4 g

Distributed by Enovachem™

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA FLOWER", "unii": "OZ0E5Y15PZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL PALMITATE", "unii": "2865993309", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE SE", "unii": "FCZ5MH785I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLISOTHIAZOLINONE", "unii": "229D0E1QFA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CAPSAICIN", "unii": "S07O44R1ZM", "classCode": "ACTIB", "strengthNumerator": "0.025", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"50565-1": "Keep out of reach of children. If swallowed, consult physician.", "50569-3": "If symptoms persist for more than seven days, discontinue use and consult physician.", "50570-1": "Do not apply to wounds or damaged skin. Do not bandage tightly.", "53414-9": "If pregnant or breast feeding, contact physician prior to use.", "Purpose": "Topical Analgesic Topical Analgesic Topical Analgesic", "Warnings": "For external use only. Avoid contact with eyes.", "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.", "Indications": "For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.", "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.", "Active Ingredients": "Methyl Salicylate 20.000% Menthol 10.00% Capsaicin 0.025%", "Additional Information": "Store at room temperature.", "Principal Display Panel - Exoten-C Label": "Exoten-C Pain Relief  Lotion 113.4 g Distributed by Enovachem™ PHARMACEUTICALS Torrance, CA 90501 (310) 320-0100"}