Gerigentle Frostyheat Pain Relief Patch 4% Lodocaine Back

Gerigentle Frostyheat Pain Relief Patch 4% Lodocaine Back
SPL v3
SPL
SPL Set ID e4427928-c063-9ca6-e053-2995a90a1aa1
Route
TOPICAL
Published
Effective Date 2022-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Kaolin Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Povidone, Unspecified Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

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

Lidocaine 4%

Purpose

Topical anesthetic

Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Uses

For temporary relief of pain

Warnings:

For external use only

Do Not Use
  • More than 1 patch at a time
  • on wounds or damaged skin
  • with heating pad
  • if you are allergic to any ingredient of this product.
Directions:

Adults and children over 12 years:

  • 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.
  • consult a physcian Children 12 years or younger:
Active Ingredient

Lidocaine 4%

Package Labeling:

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

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

When Using This Product
  • use only as directed
  • avoid contact with eyes and mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • localized skin reactions, such as rash, itching, redness, pain swelling and blistering develop
  • Condition worsens
  • 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

Uses

For temporary relief of pain

Purpose

Topical anesthetic

Warnings:

For external use only

Do Not Use (Do not use)
  • More than 1 patch at a time
  • on wounds or damaged skin
  • with heating pad
  • if you are allergic to any ingredient of this product.
Directions:

Adults and children over 12 years:

  • 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.
  • consult a physcian Children 12 years or younger:
Active Ingredient (Active ingredient)

Lidocaine 4%

Package Labeling:

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

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with eyes and mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • localized skin reactions, such as rash, itching, redness, pain swelling and blistering develop
  • Condition worsens
  • 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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:19.059627 · Updated: 2026-03-14T23:01:48.065872