83559-005

83559-005
SPL v2
SPL
SPL Set ID 1592d29d-e275-a44d-e063-6294a90ab17d
Route
TOPICAL
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (80 mg) Capsicum (16 mg) Menthol (24 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Kaolin Peppermint Oil Sorbitol Solution Povidone Water Glycerin Carboxymethylcellulose Sodium Phenoxyethanol Sodium Acrylate Propylene Glycol Ethylhexylglycerin Tartaric Acid Eucalyptus Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-07

Description

Camphor 80mg Menthol 24mg Capsicum Extract 16mg

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor 80mg Menthol 24mg Capsicum Extract 16mg

Use

For temporary relief of pains

Stop Use

·Condition worsens

·Severe skin irritation occurs

·Pain persists for more than 7 days

·Symptoms clear up and occur again within a few days

Warnings

For external use only

Questions

1-800-910-6874

Ask Doctor

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

Children under 12 years, consult doctor before use

Directions

·Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily

·Children under 12 years, consult 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

·Wash hands with soap after applying patch

·Reseal pouch containing unused patches

Do Not Use

·Do not get into eyes or on mucous membranes

·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

When Using

·Use only as directed

Active Ingredient

Camphor 80mg

Menthol 24mg

Capsicum Extract 16mg

Other Information

This product may cause allergic reaction on some individuals.Store in cool dry place away from direct sunlight.

Inactive Ingredients

Aluminum Glycinate, Ethylhexylglycerin, Eucalyptus Oil, Glycerin, Kaolin, Mentha Oil, Phenoxyethanol, Polyvinylpyrrolidone,Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitol Solution, Tartaric Acid, Water

Principal Display Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact Poison Control Center right away.


Structured Label Content

Use

For temporary relief of pains

Purpose

Topical analgesic

Stop Use

·Condition worsens

·Severe skin irritation occurs

·Pain persists for more than 7 days

·Symptoms clear up and occur again within a few days

Warnings

For external use only

Questions

1-800-910-6874

Ask Doctor

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

Children under 12 years, consult doctor before use

Directions

·Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily

·Children under 12 years, consult 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

·Wash hands with soap after applying patch

·Reseal pouch containing unused patches

Do Not Use (Do not use)

·Do not get into eyes or on mucous membranes

·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

When Using

·Use only as directed

Active Ingredient

Camphor 80mg

Menthol 24mg

Capsicum Extract 16mg

Other Information (Other information)

This product may cause allergic reaction on some individuals.Store in cool dry place away from direct sunlight.

Inactive Ingredients (Inactive ingredients)

Aluminum Glycinate, Ethylhexylglycerin, Eucalyptus Oil, Glycerin, Kaolin, Mentha Oil, Phenoxyethanol, Polyvinylpyrrolidone,Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitol Solution, Tartaric Acid, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If swallowed, get medical help or contact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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