SPL v3
SPL
SPL Set ID 4c5c0ed8-fe43-4693-83f3-25b6c16b74c6
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 g) Menthol (5 g) Capsaicin (.035 g) Lidocaine (0.5 g)
Inactive Ingredients
Acrylic Acid Aluminum Hydroxide Croscarmellose Sodium Ethylhexyl Acetate Glycerin Isopropyl Myristate Methyl Acrylate Nonoxynol-30 Sodium Polyacrylate (2500000 Mw) Polyacrylic Acid (800000 Mw) Polysorbate 80 Sorbitan Sesquioleate Starch, Corn Talc Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-08-18

Description

CAPSAICIN 0.035% LIDOCAINE 0.5% MENTHOL 5% METHYL SALICYLATE 20%


Medication Information

Indications and Usage

USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

Dosage and Administration

Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

Description

CAPSAICIN 0.035% LIDOCAINE 0.5% MENTHOL 5% METHYL SALICYLATE 20%

Section 42229-5

IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 50569-3

IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.

Section 50570-1

DO NOT USE: ON WOUNDS OR DAMAGED SKIN. CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR. IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.

Section 51727-6

Inactive Ingredients: ACRLIC ACID, ALUMINUM HYDROXIDE, CARMELLOSE SODIEM, 2-ETHYLHEXYL ACRYLATE, GLYCERIN, ISOPROPYL MYRISTATE, METHYL ACRYLATE, NONOXYNOL-30, POLYACRYLATE, POLYACRYLIC ACID, POLYSORBATE 80, SORBITAN SESQUIOLEATE, STARCH, TALC, TARTARIC ACID, TITANIUM DIOXIDE, WATER.

Section 51945-4
Section 53413-1

QUESTIONS? 888 907-2833

Section 55105-1

PURPOSE

TOPICAL ANALGESIC

TOPICAL ANESTHETIC

Section 55106-9

CAPSAICIN 0.035%

LIDOCAINE 0.5%

MENTHOL 5%

METHYL SALICYLATE 20%

Section 60561-8

OTHER INFORMATION: STORE BELOW 90°F/32°C

Warnings

Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor.


Structured Label Content

Indications and Usage (34067-9)

USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

Dosage and Administration (34068-7)

Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

Section 42229-5 (42229-5)

IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 50569-3 (50569-3)

IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.

Section 50570-1 (50570-1)

DO NOT USE: ON WOUNDS OR DAMAGED SKIN. CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR. IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.

Section 51727-6 (51727-6)

Inactive Ingredients: ACRLIC ACID, ALUMINUM HYDROXIDE, CARMELLOSE SODIEM, 2-ETHYLHEXYL ACRYLATE, GLYCERIN, ISOPROPYL MYRISTATE, METHYL ACRYLATE, NONOXYNOL-30, POLYACRYLATE, POLYACRYLIC ACID, POLYSORBATE 80, SORBITAN SESQUIOLEATE, STARCH, TALC, TARTARIC ACID, TITANIUM DIOXIDE, WATER.

Section 51945-4 (51945-4)
Section 53413-1 (53413-1)

QUESTIONS? 888 907-2833

Section 55105-1 (55105-1)

PURPOSE

TOPICAL ANALGESIC

TOPICAL ANESTHETIC

Section 55106-9 (55106-9)

CAPSAICIN 0.035%

LIDOCAINE 0.5%

MENTHOL 5%

METHYL SALICYLATE 20%

Section 60561-8 (60561-8)

OTHER INFORMATION: STORE BELOW 90°F/32°C

Warnings

Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor.


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