Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f7198485-3d68-41d2-b9b9-f932a0649310
Route
TRANSDERMAL
Published
Effective Date 2020-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (28 mg) Menthol, Unspecified Form (54 mg) Salicylic Acid (90 mg)
Inactive Ingredients
Hydrogenated C6-20 Polyolefin (100 Cst) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum Styrene/isoprene/styrene Block Copolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-23

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Purpose

Topical analgesic Topical analgesic Topical analgesic


Medication Information

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains
Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

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
  • 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

Do Not Use
  • on wounds or damaged skin with a heating pad
  • if you are allergic to any ingredients of this product
Other Information
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
Active Ingredients

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Inactive Ingredients

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

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
  • conditions 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.

Principal Display Panel 60 Patch Box Label

CVS

Health ®

Compare to the active ingredients in

Salonpas ® Pain Relieving Patch*

Pain-Relieving

Patch

CAMPHOR 3.1%

MENTHOL 6.0%

METHYL SALICYLATE 10.0%

Topical analgesic/Pain reliever

For temporary relief of minor

aches & pains:

  • Stiff neck
  • Sore shoulders
  • Backache
  • Joint pain

60 PATCHES

Contains 3 pouches with 20 patches in each

2.83 IN X 1.81 IN (7.2 cm X 4.6 cm)

Pain-relieving ointment on a breathable adhesive pad

Principal Display Panel 20 Patch Pouch Label

CVS

Health ®

Pain-Relieving

Patches

CAMPHOR 3.1%

MENTHOL 6.0%

METHYL SALICYLATE 10.0%

Topical analgesic/Pain reliever

For temporary relief of minor

aches & pains:

  • Stiff neck
  • Sore shoulders
  • Backache
  • Joint pain

20 PATCHES

2.83 IN X 1.81 IN (7.2 CM X 4.6 CM)


Structured Label Content

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains
Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Topical analgesic

Topical analgesic

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
  • 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

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

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Inactive Ingredients (Inactive ingredients)

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

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
  • conditions 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.

Principal Display Panel 60 Patch Box Label (Principal Display Panel - 60 Patch Box Label)

CVS

Health ®

Compare to the active ingredients in

Salonpas ® Pain Relieving Patch*

Pain-Relieving

Patch

CAMPHOR 3.1%

MENTHOL 6.0%

METHYL SALICYLATE 10.0%

Topical analgesic/Pain reliever

For temporary relief of minor

aches & pains:

  • Stiff neck
  • Sore shoulders
  • Backache
  • Joint pain

60 PATCHES

Contains 3 pouches with 20 patches in each

2.83 IN X 1.81 IN (7.2 cm X 4.6 cm)

Pain-relieving ointment on a breathable adhesive pad

Principal Display Panel 20 Patch Pouch Label (Principal Display Panel - 20 Patch Pouch Label)

CVS

Health ®

Pain-Relieving

Patches

CAMPHOR 3.1%

MENTHOL 6.0%

METHYL SALICYLATE 10.0%

Topical analgesic/Pain reliever

For temporary relief of minor

aches & pains:

  • Stiff neck
  • Sore shoulders
  • Backache
  • Joint pain

20 PATCHES

2.83 IN X 1.81 IN (7.2 CM X 4.6 CM)


Advanced Ingredient Data


Raw Label Data

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