SPL v1
SPL
SPL Set ID 44128b70-3172-ee37-e063-6294a90a705f
Route
TOPICAL
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsicum (22 mg) Camphor (synthetic) (110 mg) Levomenthol (33 mg)
Inactive Ingredients
Edetic Acid Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Laurocapram Polyacrylic Acid (800000 Mw) Water Dmdm Hydantoin Sodium Polyacrylate (8000 Mw) Acrylamide/sodium Acryloyldimethyltaurate Copolymer (120000 Mpa.s At 1%) Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-21

Description

Topical analgesic

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Topical analgesic

Use

For temporary relief of pain

Section 51945-4

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:apply to affected area; change patch 1 to 2 times daily

Children under 12 years of age: consult a doctor before use

How to Apply

Clean and dry affected area

Cut open pouch and remove patch

Remove protective film and apply directly to area of pain

Apply to affected area not more than 3 times daily. Do not leave on skin for more than a total of 8 hours per day

Wash hands with soap after applying patch

Reseal pouch containing unused patches

Children under 2 years of age: do not use, consult a physician

Other Information

This product may cause allergic reaction on some individuals

Store in cool dry place away from direct sunlight

Store at 15-30°C (59-86°F)

Active Ingredient(s)

Camphor 110mg +Menthol 33mg + Capsicum Extract 22mg

Inactive Ingredients

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Dihydroxyaluminum aminoacetate, DMDM hydantoin, Edetic acid, Glycerin, Laurocapram, Polyacrylic acid, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

When Using This Product:

Use only as directed

do not get into eyes or on mucous membranes. If contact occurs, rinse thoroughly with water

do not apply to wounds, damaged or irritated skin

do not bandage or cover with any type of wrap except clothing

do not use with a heating pad or apply external heat

do not use 1 hour prior to bathing or within 30 minutes after bathing

If Pregnant Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If:

Condition worsens,

Severe skin irritation occurs

Pain persist for more than 7 days

Symptoms clear up and occur again within a few days.


Structured Label Content

Use

For temporary relief of pain

Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:apply to affected area; change patch 1 to 2 times daily

Children under 12 years of age: consult a doctor before use

How to Apply

Clean and dry affected area

Cut open pouch and remove patch

Remove protective film and apply directly to area of pain

Apply to affected area not more than 3 times daily. Do not leave on skin for more than a total of 8 hours per day

Wash hands with soap after applying patch

Reseal pouch containing unused patches

Children under 2 years of age: do not use, consult a physician

Other Information (Other information)

This product may cause allergic reaction on some individuals

Store in cool dry place away from direct sunlight

Store at 15-30°C (59-86°F)

Active Ingredient(s)

Camphor 110mg +Menthol 33mg + Capsicum Extract 22mg

Inactive Ingredients (Inactive ingredients)

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Dihydroxyaluminum aminoacetate, DMDM hydantoin, Edetic acid, Glycerin, Laurocapram, Polyacrylic acid, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

When Using This Product: (When using this product:)

Use only as directed

do not get into eyes or on mucous membranes. If contact occurs, rinse thoroughly with water

do not apply to wounds, damaged or irritated skin

do not bandage or cover with any type of wrap except clothing

do not use with a heating pad or apply external heat

do not use 1 hour prior to bathing or within 30 minutes after bathing

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

If pregnant or breast feeding, ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Condition worsens,

Severe skin irritation occurs

Pain persist for more than 7 days

Symptoms clear up and occur again within a few days.


Advanced Ingredient Data


Raw Label Data

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