drug facts

drug facts
SPL v3
SPL
SPL Set ID 5a1b6192-d537-42b3-add8-22c63e7c986c
Route
topical
Published
Effective Date 2023-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (37 mg)
Inactive Ingredients
alcohol aloe vera leaf arnica montana flower camphor (synthetic) .alpha.-tocopherol acetate ilex paraguariensis leaf tea tree oil water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-02-28

Purpose

Topical analgesic

Description

Natural Menthol USP 3.7%


Medication Information

Warnings

For external use only

Flammable:

  • Do not use while smoking or near heat or flame
Uses

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

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

Topical analgesic

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
Other Information

May cause staining. Use with caution when spraying near fabric and unprotected surfaces

Inactive Ingredients

Alcohol Denatured, †Aloe Barbadensis Leaf Juice Powder, †Arnica Montana Extract, Camphor, †Ilex Paraguariensis Leaf Extract, Melaleuca Altemifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate (Vitamin E Acetate), Water.

Description

Natural Menthol USP 3.7%

Do Not Apply
  • to wounds or damaged, broken or irritated skin.
  • Do not allow contact with eyes or mucous membranes.
Active Ingredients

Natural Menthol USP 3.7%

Questions Or Comments

GameonXtreme.com ■ (888)602-7200

†Symbol before the ingredients indicates certified organic.

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. Contents under pressure. Do not store 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.
Keep Out of Reach of Children and Pets.
  • If swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel – 96g Can Label

GAME ON

Xtreme™

WARM UP SPRAY

BEFORE YOU PLAY,

USE GAME ON SPRAY

Nt wt 3.4 oz (96 g)


Structured Label Content

Warnings

For external use only

Flammable:

  • Do not use while smoking or near heat or flame
Uses

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

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

Topical analgesic

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
Other Information (Other information)

May cause staining. Use with caution when spraying near fabric and unprotected surfaces

Inactive Ingredients

Alcohol Denatured, †Aloe Barbadensis Leaf Juice Powder, †Arnica Montana Extract, Camphor, †Ilex Paraguariensis Leaf Extract, Melaleuca Altemifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate (Vitamin E Acetate), Water.

Do Not Apply (Do not apply)
  • to wounds or damaged, broken or irritated skin.
  • Do not allow contact with eyes or mucous membranes.
Active Ingredients

Natural Menthol USP 3.7%

Questions Or Comments (Questions or Comments)

GameonXtreme.com ■ (888)602-7200

†Symbol before the ingredients indicates certified organic.

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. Contents under pressure. Do not store 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.
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.
Principal Display Panel – 96g Can Label

GAME ON

Xtreme™

WARM UP SPRAY

BEFORE YOU PLAY,

USE GAME ON SPRAY

Nt wt 3.4 oz (96 g)


Advanced Ingredient Data


Raw Label Data

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