Pain Relief Patch

Pain Relief Patch
SPL v1
SPL
SPL Set ID da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.1 g) Menthol (6 g) Salicylic Acid (10 g)
Inactive Ingredients
Hydrogenated C6-20 Polyolefin (100 Cst) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum Styrene/isoprene Copolymer (28:72; 210000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Camphor 3.1% - Topical analgesic Menthol 6.0% - Topical analgesic Methyl Salicylate 10.0% - Topical analgesic

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor 3.1% - Topical analgesic Menthol 6.0% - Topical analgesic Methyl Salicylate 10.0% - Topical analgesic

Uses

Temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, muscle strains, muscle sprains, and bruises.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and consult a doctor if rash, itching or excessive skin irritation develops, condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Section 50567-7

When using this product: Use only as directed, avoid contact with eyes, mucous membranes or rashes, do not bandage tightly, do not use at the same time as other topical analgesics.

Section 50570-1

Do not use more than one patch on your body at a time, on wounds or damaged skin, with a heating pad, or if you are allergic to any ingredients of this product.

Section 51945-4

Section 53414-9

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

Warnings

For external use only.

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

Directions

Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Remove patch from film, apply to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

Children under 12 years of age: Consult a physician.

Other Information

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

Active Ingredients

Camphor 3.1% - Topical analgesic

Menthol 6.0% - Topical analgesic

Methyl Salicylate 10.0% - Topical analgesic

Inactive Ingredients

Hydrogenated poly

Pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate

Petroleum

Styrene/isoprene copolymer


Structured Label Content

Uses

Temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, muscle strains, muscle sprains, and bruises.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and consult a doctor if rash, itching or excessive skin irritation develops, condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Section 50567-7 (50567-7)

When using this product: Use only as directed, avoid contact with eyes, mucous membranes or rashes, do not bandage tightly, do not use at the same time as other topical analgesics.

Section 50570-1 (50570-1)

Do not use more than one patch on your body at a time, on wounds or damaged skin, with a heating pad, or if you are allergic to any ingredients of this product.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Topical analgesic

Warnings

For external use only.

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

Directions

Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Remove patch from film, apply to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

Children under 12 years of age: Consult a physician.

Other Information

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

Active Ingredients

Camphor 3.1% - Topical analgesic

Menthol 6.0% - Topical analgesic

Methyl Salicylate 10.0% - Topical analgesic

Inactive Ingredients

Hydrogenated poly

Pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate

Petroleum

Styrene/isoprene copolymer


Advanced Ingredient Data


Raw Label Data

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