SPL v1
SPL
SPL Set ID 3cd20f1f-033f-f698-e063-6294a90a89eb
Route
TOPICAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (91 mg) Salicylic Acid (290 mg)
Inactive Ingredients
Boswellia Serrata Whole Dimethyl Sulfone Eucalyptus Globulus Leaf Oil Mentha Arvensis Leaf Oil Arnica Montana Flower Alcohol Propylene Glycol Water Trolamine Ilex Paraguariensis Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Menthol 9.1% Methyl Salicylate 29.0%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 9.1% Methyl Salicylate 29.0%

Uses

Relieves minor pain of muscles and joints associated with:

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains
Warnings

For external use only

Directions
  • shake well
  • Adults and children 12 years of age and older: Spray product on area not more than 1 to 3 times daily
  • Children under 12 years of age: Ask a doctor
Do Not Apply
  • to wounds or damaged, broken, or irritated skin.
  • Do not allow contact with eyes or mucous membranes
Other Information
  • May cause staining. Use with caution when spraying near fabric and unprotected surfaces.
Active Ingredients

Menthol 9.1%

Methyl Salicylate 29.0%

Inactive Ingredients

Alcohol Denatured, Arnica Montana Flower Extract, Boswellia Serrata Extract, Dimethyl Sulfone, Eucalyptus Globulus Leaf Oil, Ilex Paraguariensis Leaf Extract, Mentha Arvensis Leaf Oil, Propylene Glycol, Treithanolamine, Water

When Using This Product
  • Keep out of eyes
  • Do not bandage tightly
  • Do not use with a heating pad
  • Use only as directed
  • Do not puncture or incinerate
  • Do not sotre at temperatures above 120°F
Stop Use and Ask A Doctor If
  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Needed for longer than a week
If Pregnant Or Breast Feeding,

ask a health professional before use.

Principal Display Panel 96 G Label

GAME ON

XTREME

Warm-up

Spray

BEFORE YOU PLAY,

USE GAME ON SPRAY

Net Wt. 3.4 oz (96 g)

Filled & Packaged in USA

Keep Out of Reach of Children and Pets.

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


Structured Label Content

Uses

Relieves minor pain of muscles and joints associated with:

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains
Purpose

Topical analgesic

Warnings

For external use only

Directions
  • shake well
  • Adults and children 12 years of age and older: Spray product on area not more than 1 to 3 times daily
  • Children under 12 years of age: Ask a doctor
Do Not Apply (Do not apply)
  • to wounds or damaged, broken, or irritated skin.
  • Do not allow contact with eyes or mucous membranes
Other Information (Other information)
  • May cause staining. Use with caution when spraying near fabric and unprotected surfaces.
Active Ingredients (Active ingredients)

Menthol 9.1%

Methyl Salicylate 29.0%

Inactive Ingredients (Inactive ingredients)

Alcohol Denatured, Arnica Montana Flower Extract, Boswellia Serrata Extract, Dimethyl Sulfone, Eucalyptus Globulus Leaf Oil, Ilex Paraguariensis Leaf Extract, Mentha Arvensis Leaf Oil, Propylene Glycol, Treithanolamine, Water

When Using This Product (When using this product)
  • Keep out of eyes
  • Do not bandage tightly
  • Do not use with a heating pad
  • Use only as directed
  • Do not puncture or incinerate
  • Do not sotre at temperatures above 120°F
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Needed for longer than a week
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Principal Display Panel 96 G Label (Principal Display Panel - 96 g Label)

GAME ON

XTREME

Warm-up

Spray

BEFORE YOU PLAY,

USE GAME ON SPRAY

Net Wt. 3.4 oz (96 g)

Filled & Packaged in USA

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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


Advanced Ingredient Data


Raw Label Data

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