Orythia Pain Relieving Lidocaine Patch
FDA Label NDC 75568-035

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Planet (anhui) Pharmaceutical Co., Ltd. for the product Orythia Pain Relieving Lidocaine (NDC 75568-035). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Lidocaine 4.0%

Purpose

Topical anesthetic

Use

For temporary relief of pain

Warnings

For external us only

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

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

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.

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

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-(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

Package Labeling:

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