Knee Pain Relief Gel-patch
FDA Label NDC 83602-178

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. for the product Knee Pain Relief Gel-patch (NDC 83602-178). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments:

→ Label

Active Ingredients

Lidocaine 4% ...... Purpose: Topical anesthetic

Menthol 1% ...... Purpose: Topical analgesic

Purpose

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Uses

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

Warnings

For external use only

Do Not Use

· more than 1 patch on your body at a time or with other topical anesthetics at the same time

· on wounds or damaged skin

· with a heating pad or device

· with other ointments, creams, sprays, or liniments

· if you are allergic to any ingredients of this product

When Using This Product

· use only as directed

· avoid contact with the eyes, mucous membranes, or rashes

· do not bandage tightly

· dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use And Ask A Doctor If

· localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering

· condition worsens

· 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 accidentally , get medical help or contact with Poison Control Center immediately.

Directions

Adults and Children above 12 years old

· Clean and dry the affected area.

· Tear off the protective film and apply the exposed part of the patch to the affected area.

· Carefully remove remaining film while pressing the patch firmly on the skin.

· Apply 1 patch at a time to affected area, not more than 3 to 4 times daily.

· Remove patch from the skin after at most 8-hour application

Children under age of 12:Consult a doctor

Other Information

· Store at 20°C to 25°C（68°F - 77°F)

· Store in a cool dry place away from direct sunlight

Inactive Ingredients

Dihydroxyaluminium Aminoacetate , Edetate Disodium , Glycerin , Hydroxyacetophenone , Kaolin , L(+)-Tartaric Acid , Mineral oil , Polysorbate 80 , Polyacrylic Acid ,Polyvinylpyrrolidone K90 , Propylene Glycol , Sodium Polyacrylate , Titanium Dioxide , Water.