Topcare Health Extra Strength Pain Relief Patch 40 Ct 15679a

Topcare Health Extra Strength Pain Relief Patch 40 Ct 15679a
SPL v5
SPL
SPL Set ID dac364ef-6dcd-3fc6-e053-2a95a90a9bb2
Route
TOPICAL
Published
Effective Date 2022-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (0.012 mg) Menthol (0.057 mg) Salicylic Acid (0.063 mg)
Inactive Ingredients
Glyceryl Rosinate Natural Latex Rubber Petrolatum Zinc Oxide Polyisobutylene (1000 Mw) Lanolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-08

Description

Active ingredients Purposes Camphor 1.2%.......................................Topical analgesic Menthol 5.7%.........................................Topical analgesic Methyl salicylate 6.3%............................Topical analgesic


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

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

Distributed by:

Topco Associates LLC

Elk Grove IL 60007

Made in China

Description

Active ingredients Purposes Camphor 1.2%.......................................Topical analgesic Menthol 5.7%.........................................Topical analgesic Methyl salicylate 6.3%............................Topical analgesic

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
  • 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

  • redness is present or irritation or rash develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7

When using this product

  • do not use otherwise than as directed
  • avoid contact with eyes, mucous membranes or rashes
  • 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 50569-3

Ask a doctor before use if you have redness over the affected area.

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

glyceryl rosinate, lanolin, natural latex rubber, petrolatum, polyisobutylene, zinc oxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

  • temporarily relieves the minor aches and pains of muscles and joints associated with:
  • sprains
  • simple backache
  • arthritis
  • strains
  • bruises
Section 55106-9

Active ingredients Purposes

Camphor 1.2%.......................................Topical analgesic

Menthol 5.7%.........................................Topical analgesic

Methyl salicylate 6.3%............................Topical analgesic


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)

Distributed by:

Topco Associates LLC

Elk Grove IL 60007

Made in China

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 at room temperature 20-25°C (68-77°F)
  • 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

  • redness is present or irritation or rash develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • do not use otherwise than as directed
  • avoid contact with eyes, mucous membranes or rashes
  • 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 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area.

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

glyceryl rosinate, lanolin, natural latex rubber, petrolatum, polyisobutylene, 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

  • temporarily relieves the minor aches and pains of muscles and joints associated with:
  • sprains
  • simple backache
  • arthritis
  • strains
  • bruises
Section 55106-9 (55106-9)

Active ingredients Purposes

Camphor 1.2%.......................................Topical analgesic

Menthol 5.7%.........................................Topical analgesic

Methyl salicylate 6.3%............................Topical analgesic


Advanced Ingredient Data


Raw Label Data

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