EXOTEN-C

Manufacturer: Asclemed USA, Inc.
Effective date: 2023-10-16
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:56:48

Label at a glance#

ProductEXOTEN-C

Active ingredientMETHYL SALICYLATE, MENTHOL, CAPSAICIN

Label structure8 sections

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact(310) 320-0100

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 20.000%

Menthol 10.00%

Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Indications

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - DO NOT USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Store at room temperature.

Other Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exoten-C

Pain Relief  Lotion

113.4 g

Distributed by Enovachem™

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

Principal Display Panel - Exoten-C Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1870112	capsaicin 0.025 % / menthol 10 % / methyl salcylate 20 % Topical Lotion	PSN	4
1870112	capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical Lotion	SCD	4
1870112	capsaicin 0.025 % / menthol 10 % / methyl salcylate 20 % Topical Lotion	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-947-01	EXOTEN-C	113.4 g in 1 BOTTLE	LOTION	113.4		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-947	EXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [ASCLEMED USA, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20231016_76ed37e0-64b5-4abe-a03c-3dc7084a3919.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-947-01	GM - Gram	76420-947	5b6fad93-42e5-4805-a072-f1bbeed576b6	1	2017-03-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

EXOTEN-C
METHYL SALICYLATE, MENTHOL, CAPSAICIN
ALOE VERA LEAF
WATER
ARNICA MONTANA FLOWER
CETOSTEARYL ALCOHOL
ETHYLHEXYL PALMITATE
GLYCERYL STEARATE SE
METHYLISOTHIAZOLINONE
PEG-100 STEARATE
.ALPHA.-TOCOPHEROL
METHYL SALICYLATE
SALICYLIC ACID
MENTHOL
CAPSAICIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76420-947	76420-947-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
WATER	059QF0KO0R	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
ETHYLHEXYL PALMITATE	2865993309	IACT
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
PEG-100 STEARATE	YD01N1999R	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
METHYL SALICYLATE	LAV5U5022Y	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
CAPSAICIN	S07O44R1ZM	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXOTEN-C	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Asclemed USA, Inc.	76ed37e0-64b5-4abe-a03c-3dc7084a3919	2023-10-16	Warnings	Exact identifier ndc (package): 76420-947-01 ndc (product): 76420-947 ndc11 (package): 76420094701 spl id: 07cec02c-17d3-145d-e063-6294a90a0fb3 spl set id: 76ed37e0-64b5-4abe-a03c-3dc7084a3919

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.