soundbody medicated pain relief patch

soundbody medicated pain relief patch
SPL v2
SPL
SPL Set ID 9f07da88-b008-5b3f-e053-2995a90ac7d4
Routes
topical percutaneous transdermal
Published
Effective Date 2020-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (31 mg) menthol (60 mg) salicylic acid (100 mg)
Inactive Ingredients
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) hydrogenated poly(c6-14 olefin; 2 cst) liquid petroleum

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2002-02-19

Purpose

Topical analgesic

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%


Medication Information

Warnings

For external use only

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

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

Children under 12 years of age: consult a doctor

Other Information
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
Inactive Ingredients

hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Principal Display Panel

Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Allergy Alert:

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

Active Ingredients

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

When Using This Product
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • rash, itching or excessive skin irritation develops
  • contisions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

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

Children under 12 years of age: consult a doctor

Other Information (Other information)
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
Inactive Ingredients (Inactive ingredients)

hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Principal Display Panel

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Allergy Alert: (Allergy alert:)

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

Active Ingredients (Active ingredients)

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash, itching or excessive skin irritation develops
  • contisions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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