Topcare 2385 Medicated Pain Relieving Patch 60ct

Topcare 2385 Medicated Pain Relieving Patch 60ct
SPL v1
SPL
SPL Set ID 4953c12b-ca6d-d21e-e063-6294a90ac990
Route
TOPICAL
Published
Effective Date 2026-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (60 mg) Camphor (synthetic) (31 mg) Salicylic Acid (100 mg)
Inactive Ingredients
Lanolin Glyceryl Rosinate Zinc Oxide Polyisobutylene (800000 Mw) Styrene/isoprene/styrene Block Copolymer Butylated Hydroxytoluene Aluminum Silicate Polyisobutylene (85000 Mw) Titanium Dioxide Natural Latex Rubber Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-26

Description

Active ingredients Purpose Camphor 3.1%............................................................Topical analgesic Menthol 6.0%..............................................................Topical analgesic Methyl salicylate 10.0%...............................................Topical analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Directions

 adults and children 12 years of age and older:

 clean and dry affected area

 remove patch from film

 apply to affected area no more than 3 to 4 times daily

 do not wear patch for more than 4 hours

 children under 12 years of age: consult a doctor

Dosage and Administration

Questions or comments?

Call 1-888-423-0139

Distributed By TOPCO ASSOCIATES LLC

ITASCA, IL 60143 @TOPCO UNXA0525

Questions? 1-888-423-0139

[email protected] www.topcarebrand.com

MADE IN CHINA

Description

Active ingredients Purpose Camphor 3.1%............................................................Topical analgesic Menthol 6.0%..............................................................Topical analgesic Methyl salicylate 10.0%...............................................Topical analgesic

Section 44425-7

Other information

 store at room temperature 20-25ºC (68-77º)

 avoid storing product in direct sunlight

 protect product from excessive moisture

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 ask a doctor if

 condition worsens, or symptoms persist for more than 7 days, or

clear up and occur again within a few days

 redness is present or irritation or rash develops

 a severe burning sensation occurs

Section 50567-7

When using this product

 use only as directed

 avoid contact with the eyes, or mucous membranes

 do not bandage tightly

 discontinue use at least 1 hour before a bath or shower

 do not use immediately after a bath or shower

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

 on a child under 12 years of age with arthritis-like conditions

Section 51727-6

Inactive ingredients aluminum silicate, butylated

hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, paraffin,

polyisobutylene (85000 MW), polyisobutylene (800000 MW),

styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

 temporary relief of minor aches and pains of muscles and joints

associated with:

 arthritis  simple backache  sprains  bruises

 strains

Section 55106-9

Active ingredients Purpose

Camphor 3.1%............................................................Topical analgesic

Menthol 6.0%..............................................................Topical analgesic

Methyl salicylate 10.0%...............................................Topical analgesic

Section 60561-8

Allergy alert: If prone to allergic reaction from aspirin or salicylates,

consult a doctor before use.


Structured Label Content

Indications and Usage (34067-9)

Directions

 adults and children 12 years of age and older:

 clean and dry affected area

 remove patch from film

 apply to affected area no more than 3 to 4 times daily

 do not wear patch for more than 4 hours

 children under 12 years of age: consult a doctor

Dosage and Administration (34068-7)

Questions or comments?

Call 1-888-423-0139

Distributed By TOPCO ASSOCIATES LLC

ITASCA, IL 60143 @TOPCO UNXA0525

Questions? 1-888-423-0139

[email protected] www.topcarebrand.com

MADE IN CHINA

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 44425-7 (44425-7)

Other information

 store at room temperature 20-25ºC (68-77º)

 avoid storing product in direct sunlight

 protect product from excessive moisture

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 ask a doctor if

 condition worsens, or symptoms persist for more than 7 days, or

clear up and occur again within a few days

 redness is present or irritation or rash develops

 a severe burning sensation occurs

Section 50567-7 (50567-7)

When using this product

 use only as directed

 avoid contact with the eyes, or mucous membranes

 do not bandage tightly

 discontinue use at least 1 hour before a bath or shower

 do not use immediately after a bath or shower

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

 on a child under 12 years of age with arthritis-like conditions

Section 51727-6 (51727-6)

Inactive ingredients aluminum silicate, butylated

hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, paraffin,

polyisobutylene (85000 MW), polyisobutylene (800000 MW),

styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

 temporary relief of minor aches and pains of muscles and joints

associated with:

 arthritis  simple backache  sprains  bruises

 strains

Section 55106-9 (55106-9)

Active ingredients Purpose

Camphor 3.1%............................................................Topical analgesic

Menthol 6.0%..............................................................Topical analgesic

Methyl salicylate 10.0%...............................................Topical analgesic

Section 60561-8 (60561-8)

Allergy alert: If prone to allergic reaction from aspirin or salicylates,

consult a doctor before use.


Advanced Ingredient Data


Raw Label Data

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