orythia maximum strength 4% lidocaine pain relieving gel patches

orythia maximum strength 4% lidocaine pain relieving gel patches
SPL v2
SPL
SPL Set ID 6d6b59f9-f614-4e3c-b07b-32b4591d39f2
Route
topical
Published
Effective Date 2025-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (40 mg)
Inactive Ingredients
propylene glycol polyoxyl 40 hydrogenated castor oil vanillyl butyl ether phenoxyethanol glycerin dihydroxyaluminum aminoacetate titanium dioxide tartaric acid urea water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-07-20

Purpose

Topical anesthetic

Description

Lidocaine 4.0%


Medication Information

Warnings

For external use only

Purpose

Topical anesthetic

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove film from patch and apply to the skin

Children under 12 years of age: consult a doctor

Other Information
  • Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture
Inactive Ingredients

Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Vanillyl Butyl Ether, Phenoxyethanol, 3-2-(Ethylhexy) oxyl-1, 2-Propandiol, Glycerol, Azone a-Tocopherol Acetate, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, CMC-2Na, Titanium Dioxide, Fumed Silica, Tartaric Acid, Polyacrylic Acid, Urea, Water

Description

Lidocaine 4.0%

Questions?

626-839-9001 [email protected]

Use

For temporary relief of pain

Drug Facts

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 active ingredients of this product
Active Ingredient

Lidocaine 4.0%

Package Labeling:

When Using This Product
  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes, mucous membranes or rashes
Stop Use and Ask A Doctor If
  • symptoms persist for more than 7 days
  • condition worsen
  • symptoms clear up and occur again within a few days
  • localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
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

Warnings (WARNINGS)

For external use only

Purpose

Topical anesthetic

Directions (DIRECTIONS)

Adults and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove film from patch and apply to the skin

Children under 12 years of age: consult a doctor

Other Information (OTHER INFORMATION)
  • Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture
Inactive Ingredients (INACTIVE INGREDIENTS)

Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Vanillyl Butyl Ether, Phenoxyethanol, 3-2-(Ethylhexy) oxyl-1, 2-Propandiol, Glycerol, Azone a-Tocopherol Acetate, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, CMC-2Na, Titanium Dioxide, Fumed Silica, Tartaric Acid, Polyacrylic Acid, Urea, Water

Questions? (QUESTIONS?)

626-839-9001 [email protected]

Use

For temporary relief of pain

Drug Facts (DRUG FACTS)

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 active ingredients of this product
Active Ingredient (Active ingredient)

Lidocaine 4.0%

Package Labeling:

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes, mucous membranes or rashes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms persist for more than 7 days
  • condition worsen
  • symptoms clear up and occur again within a few days
  • localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
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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