005 Pain Patch

005 Pain Patch
SPL v2
SPL
SPL Set ID 44e058fc-e1c0-742b-e063-6294a90ad225
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g) Camphor (natural) (3.1 g) Menthol (6 g)
Inactive Ingredients
Acrylamide Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Camphor 3.1%, Menthol 6.0%, Methyl salicylate 10.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Indications and Usage

Uses

For temporary relief of minor aches & pains of muscles & joints associated with:

- Arthritis

- Simple backache

- Strains

- Bruises

- Sprains

Dosage and Administration

Directions

- Adults and children 12 years of age and over:

- clean and dry affected area remove patch from film

- apply to affected area not more than 3 to 4 times daiy

- remove patch from the skin after at most 8-hour application

Children under 12 years of age:

consult a doctor

Description

Camphor 3.1%, Menthol 6.0%, Methyl salicylate 10.0%

Section 44425-7

Other information

Store in a clean, dry place outside of direct sunlight. Protect product form excessive moisture.

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

- Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur

- Conditions worsen

- Symptoms persist for more than 7 days

- Symptoms clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional before use.

Section 50567-7

When using this product

- Use only as directed

- Avoid contact with the eyes, mucous membranes or rashes

- Do not bandage tightly

Section 50570-1

Do not use

- On wounds or damaged skin

- With a heating pad

- If you are allergic to any ingredients of this product

Section 51727-6

Inactive ingredients

Acrylamide, glycerin, purified water

Section 51945-4

Section 55105-1

Topical analgesic

Section 55106-9

Camphor 3.1%, Menthol 6.0%, Methyl salicylate 10.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

For temporary relief of minor aches & pains of muscles & joints associated with:

- Arthritis

- Simple backache

- Strains

- Bruises

- Sprains

Dosage and Administration (34068-7)

Directions

- Adults and children 12 years of age and over:

- clean and dry affected area remove patch from film

- apply to affected area not more than 3 to 4 times daiy

- remove patch from the skin after at most 8-hour application

Children under 12 years of age:

consult a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Section 44425-7 (44425-7)

Other information

Store in a clean, dry place outside of direct sunlight. Protect product form excessive moisture.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

- Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur

- Conditions worsen

- Symptoms persist for more than 7 days

- Symptoms clear up and occur again within a few days

If pregnant or breastfeeding, ask a health professional before use.

Section 50567-7 (50567-7)

When using this product

- Use only as directed

- Avoid contact with the eyes, mucous membranes or rashes

- Do not bandage tightly

Section 50570-1 (50570-1)

Do not use

- On wounds or damaged skin

- With a heating pad

- If you are allergic to any ingredients of this product

Section 51727-6 (51727-6)

Inactive ingredients

Acrylamide, glycerin, purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Camphor 3.1%, Menthol 6.0%, Methyl salicylate 10.0%


Advanced Ingredient Data


Raw Label Data

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