Puregen Labs Pain Relief 4% Lidocaine Patch

Puregen Labs Pain Relief 4% Lidocaine Patch
SPL v1
SPL
SPL Set ID 9dff40d8-8d7e-4629-bea5-987f5e68477d
Route
TOPICAL
Published
Effective Date 2024-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Water Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Methylparaben Polyvinyl Alcohol, Unspecified Propylene Glycol Propylparaben Carboxymethylcellulose Sodium, Unspecified Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-03

Description

Lidocaine 4.00 %

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4.00 %

Uses:
  • For the 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 a heating pad
  • If you are allergic to any ingredients of this product
Drug Facts

Questions?

call toll-free 1-800-630-8895

Directions:
  • Adults andchildren 12 years of age and older:
  • Clean and dry the affected area
  • Apply a patch at a time to the affected area; not more than 3 or 4 times daily to the affected area
  • Remove the patch from the skin after at most 8 hours of application
  • Children under 12 years of age: consult a doctor.
Active Ingredient

Lidocaine 4.00 %

Package Labeling:

Other Information:
  • Store at 20-25°C (68-77°F) and protect from moisture.
Inactive Ingredients

Aqua (Deionized Water), Dihydroxyaluminum Aminoacetate, Disodium EDTA, Glycerin, Methylparaben, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Carboxymethyl Cellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

When Using This Product
  • Avoid contact with the eyes
Stop Use and Ask A Doctor If
  • localized skin reactions occur, such as rash, itching, redness, irritation
  • 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 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 a heating pad
  • If you are allergic to any ingredients of this product
Drug Facts

Questions?

call toll-free 1-800-630-8895

Directions:
  • Adults andchildren 12 years of age and older:
  • Clean and dry the affected area
  • Apply a patch at a time to the affected area; not more than 3 or 4 times daily to the affected area
  • Remove the patch from the skin after at most 8 hours of application
  • Children under 12 years of age: consult a doctor.
Active Ingredient (Active ingredient)

Lidocaine 4.00 %

Package Labeling:

Other Information: (Other information:)
  • Store at 20-25°C (68-77°F) and protect from moisture.
Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Dihydroxyaluminum Aminoacetate, Disodium EDTA, Glycerin, Methylparaben, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Carboxymethyl Cellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

When Using This Product (When using this product)
  • Avoid contact with the eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • localized skin reactions occur, such as rash, itching, redness, irritation
  • 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

All Sections (JSON)