1454 Lidocaine Pain Relief Gel-patch Ndc 67777-009-40

1454 Lidocaine Pain Relief Gel-patch Ndc 67777-009-40
SPL v11
SPL
SPL Set ID 960e4240-cd09-2560-e053-2a95a90a7bcf
Route
TOPICAL
Published
Effective Date 2024-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg)
Inactive Ingredients
Silicon Dioxide Urea Polyacrylic Acid (800000 Mw) Carboxymethylcellulose Sodium, Unspecified Titanium Dioxide Ethylhexylglycerin Peg-40 Hydrogenated Castor Oil .alpha.-tocopherol Acetate Sodium Polyacrylate (2500000 Mw) Propylene Glycol Dihydroxyaluminum Aminoacetate Glycerin Phenoxyethanol Tartaric Acid Water Vanillyl Butyl Ether Laurocapram

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-27
Description

Lidocaine 4%

Medication Information

Description

Lidocaine 4%

Use

For temporary relief of pain

Label

Lidocaine Pain Relief Patch

Puropose

Topical Anesthetic

Warnings

For External Use Only

Directions

Adults and children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Patch should not be applied longer than an 8 hour period

Children under 12 years of age: Consult a doctor

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
Questions?

1-888-DYNAREX

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

Active Ingredients

Lidocaine 4%

Inactive Ingredients

.

.Alpha.-Tocopherol Acetate, Azone, Carboxymethylcellulose Sodium , unspecified, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Fumed Silica, Glycerol, Phenoxyethanol, Polyacrylic Acid (800000MW), Polyoxyl 40 Hydrogenated Castor Oil, Propylene Glycol, Sodium Polyacrylate (2500000 MW), Tartaric Acid, Titanium Dioxide, Urea, Vanillyl Butyl Ether, Water

When Using This Product
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
  • Single use only
Stop Use and Ask A Doctor If
  • Localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
  • Conditions worsen
  • 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 professional before use

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Use

For temporary relief of pain

Label

Lidocaine Pain Relief Patch

Puropose

Topical Anesthetic

Warnings

For External Use Only

Directions

Adults and children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Patch should not be applied longer than an 8 hour period

Children under 12 years of age: Consult a doctor

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
Questions?

1-888-DYNAREX

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

Active Ingredients

Lidocaine 4%

Inactive Ingredients

.

.Alpha.-Tocopherol Acetate, Azone, Carboxymethylcellulose Sodium , unspecified, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Fumed Silica, Glycerol, Phenoxyethanol, Polyacrylic Acid (800000MW), Polyoxyl 40 Hydrogenated Castor Oil, Propylene Glycol, Sodium Polyacrylate (2500000 MW), Tartaric Acid, Titanium Dioxide, Urea, Vanillyl Butyl Ether, Water

When Using This Product (When using this product)
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
  • Single use only
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
  • Conditions worsen
  • 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 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 (1-800-222-1222) right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:27.235006 · Updated: 2026-03-14T23:12:39.597935