Dirt Pain Relieving Gel

Dirt Pain Relieving Gel
SPL v2
SPL
SPL Set ID 89c80a8f-227d-4ec0-9327-683892e73b6a
Route
TOPICAL
Published
Effective Date 2022-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Flower Indian Frankincense Calendula Officinalis Flower Ethylhexylglycerin Eucalyptus Oil Glycerin Ilex Paraguariensis Leaf Tea Tree Oil Dimethyl Sulfone Phenoxyethanol Polysorbate 20 Propylene Glycol .alpha.-tocopherol Acetate Trolamine Activated Charcoal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-03

Description

Menthol 4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 4%

Uses:

For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.

Warnings:

For external use only

Drug Facts

Directions:

Adults and children over 12 years of age: 

Children 12 years or younger: ask a doctor

  • apply generously to affected areas
  • rub into affected area until absorbed into the skin
  • repeat as necessary, but no more than 4 times daily
Do Not Use 
  • on damaged or brokin skin.
Package Labeling:

Active Ingredients:

Menthol 4%

Inactive Ingredients:

Activated Charcoal, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Ilex Paraguariensis (Yerba Mate') Extract, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E), Triethanolamine.

When Using This Product
  • Avoid contact with the eyes.
  • Do not bandage tightly.
Stop Use and Ask A Doctor If
  • condition worsens, or if symptoms persist for more than 7 days or 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 the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.

Purpose

Topical Analgesic

Warnings:

For external use only

Drug Facts

Directions:

Adults and children over 12 years of age: 

Children 12 years or younger: ask a doctor

  • apply generously to affected areas
  • rub into affected area until absorbed into the skin
  • repeat as necessary, but no more than 4 times daily
Do Not Use  (Do not use )
  • on damaged or brokin skin.
Package Labeling:

Active Ingredients:

Menthol 4%

Inactive Ingredients:

Activated Charcoal, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Ilex Paraguariensis (Yerba Mate') Extract, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E), Triethanolamine.

When Using This Product (When using this product)
  • Avoid contact with the eyes.
  • Do not bandage tightly.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, or if symptoms persist for more than 7 days or 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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