SPL v4
SPL
SPL Set ID a4ddb2b9-d023-4c8c-9285-93d51f93207d
Routes
TOPICAL PERCUTANEOUS TRANSDERMAL
Published
Effective Date 2024-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.10 g) Menthol (10.00 g) Salicylic Acid (15.00 g)
Inactive Ingredients
Ammonium Acryloyldimethyltaurate/vp Copolymer Dimethyl Isosorbide Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-01

Description

Camphor 3.1% Menthol 10.0% Methyl salicylate 15.0%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor 3.1% Menthol 10.0% Methyl salicylate 15.0%

Uses

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

  • simple backache
  • sprains
  • strains
  • arthritis
  • bruises
Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • apply a dime sized portion to the affected area
  • massage thoroughly until absorbed into skin
  • apply to affected area not more than 3 to 4 times daily

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
Flammable:

Keep away from fire or flame.

Allergy Alert:

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

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store at 20-25C (68-77F)
  • Store with lid closed tightly
Active Ingredients

Camphor 3.1%

Menthol 10.0%

Methyl salicylate 15.0%

Inactive Ingredients

ammonium acryloyldimethyltaurate/VP copolymer, dimethyl isosorbide, propylene glycol, SD alcohol 40-B, water

Questions Or Comments?

Toll free 1-800-826-8861

www.salonpas.us

Principal Display Panel

Hisamitsu

Non-Greasy Gel

Salonpas DEEP Relieving Gel

TOPICAL ANALGESIC

3 Powerful Pain Fighting Ingredients

Fast-Acting

Fast-Absorbing

MADE IN USA

2.75 OZ (78 g)

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
  • conditions worsen
  • skin reactions such are redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • 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

Uses

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

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

Topical analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • apply a dime sized portion to the affected area
  • massage thoroughly until absorbed into skin
  • apply to affected area not more than 3 to 4 times daily

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
Flammable:

Keep away from fire or flame.

Allergy Alert: (Allergy alert:)

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

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store at 20-25C (68-77F)
  • Store with lid closed tightly
Active Ingredients (Active ingredients)

Camphor 3.1%

Menthol 10.0%

Methyl salicylate 15.0%

Inactive Ingredients (Inactive ingredients)

ammonium acryloyldimethyltaurate/VP copolymer, dimethyl isosorbide, propylene glycol, SD alcohol 40-B, water

Questions Or Comments? (Questions or comments?)

Toll free 1-800-826-8861

www.salonpas.us

Principal Display Panel

Hisamitsu

Non-Greasy Gel

Salonpas DEEP Relieving Gel

TOPICAL ANALGESIC

3 Powerful Pain Fighting Ingredients

Fast-Acting

Fast-Absorbing

MADE IN USA

2.75 OZ (78 g)

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)
  • conditions worsen
  • skin reactions such are redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • 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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