Gerigentle Frostyheat Pain Relief Patch Back

Gerigentle Frostyheat Pain Relief Patch Back
SPL v3
SPL
SPL Set ID e442b8ec-a3de-65e8-e053-2995a90af3ec
Route
TOPICAL
Published
Effective Date 2022-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Glycerin Dihydroxyaluminum Aminoacetate Methylparaben Propylparaben Titanium Dioxide Kaolin Polysorbate 80 Propylene Glycol Tartaric Acid Povidone, Unspecified Water Petrolatum Carboxymethylcellulose Sodium, Unspecified Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-16

Description

Menthol 5%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Menthol 5%

Use
  • Temporarily relieves minor aches and pains of muscles and joints due to
  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises.
Warnings:

For external use only

Do Not Use
  • on wounds or damaged skin
  • with heating pad
  • if you are allergic to any ingredient of this product.
Directions:

Adults and children 12 years of age and over:Clean and dry affected area.

Children under 12 years of age: consult a physician.

  • clean and dry affected area
  • remove film from patch and apply to skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
  • wear each patch up to 8 hours maximum.
Active Ingredient

Menthol 5%

Package Labeling:

Other Information:
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients:

Glycerin, Sodium polyacrylate, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid, Water, Petrolatum, CMC, Mineral Oil.

When Using This Product
  • use only as directed
  • avoid contact with eyes and mucous membranes or rashes
Stop Use and Ask A Doctor If
  • conditions worsen
  • excessive redness or irritation is present
  • 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 care professional before use.

Keep Out of Reach of Children and Pets.

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


Structured Label Content

Use
  • Temporarily relieves minor aches and pains of muscles and joints due to
  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises.
Purpose

Topical anesthetic

Warnings:

For external use only

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with heating pad
  • if you are allergic to any ingredient of this product.
Directions:

Adults and children 12 years of age and over:Clean and dry affected area.

Children under 12 years of age: consult a physician.

  • clean and dry affected area
  • remove film from patch and apply to skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
  • wear each patch up to 8 hours maximum.
Active Ingredient (Active ingredient)

Menthol 5%

Package Labeling:

Other Information: (Other information:)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients: (Inactive ingredients:)

Glycerin, Sodium polyacrylate, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid, Water, Petrolatum, CMC, Mineral Oil.

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with eyes and mucous membranes or rashes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions worsen
  • excessive redness or irritation is present
  • 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 care 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.


Advanced Ingredient Data


Raw Label Data

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