Orythia Pain Relieving Gel Patch 4% Lidocaine

Orythia Pain Relieving Gel Patch 4% Lidocaine
SPL v1
SPL
SPL Set ID d658d495-dd2c-40b7-9446-6f10040ed55e
Route
TOPICAL
Published
Effective Date 2025-06-24
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 Laurocapram Dihydroxyaluminum Aminoacetate Titanium Dioxide Tartaric Acid Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-25

Description

Lidocaine 4.0%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4.0%

Use

For temporary relief of pain

Warnings

For external us only

Directions

Adults and children 12 years of age over:

• clear 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

Drug Facts

Do Not Use

• more than 1 patch at a time • with a heating pad

• on wounds or damaged skin • if you are allergic to any ingredients of this product

Questions?

1-888-655-1558 [email protected]

Active Ingredient

Lidocaine 4.0%

Other Information

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

Package Labeling:

Inactive Ingredients

Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Vanillyl Butyl Ether, Phenoxyethanol, 3-2-(Ethylhexyl)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

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

• conditions worsen

• sympotms clear up and occur again within a few days

• localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop

Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding, 

ask a health professional before use


Structured Label Content

Use

For temporary relief of pain

Purpose

Topical anesthetic

Warnings (WARNINGS)

For external us only

Directions (DIRECTIONS)

Adults and children 12 years of age over:

• clear 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

Drug Facts (DRUG FACTS)

Do Not Use (Do not use)

• more than 1 patch at a time • with a heating pad

• on wounds or damaged skin • if you are allergic to any ingredients of this product

Questions? (QUESTIONS?)

1-888-655-1558 [email protected]

Active Ingredient (Active ingredient)

Lidocaine 4.0%

Other Information (OTHER INFORMATION)

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

Package Labeling:

Inactive Ingredients (INACTIVE INGREDIENTS)

Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Vanillyl Butyl Ether, Phenoxyethanol, 3-2-(Ethylhexyl)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

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

• conditions worsen

• sympotms clear up and occur again within a few days

• localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop

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.

If Pregnant Or Breast Feeding,  (If pregnant or breast feeding, )

ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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