4% Lidocaine Pain Relief Patch
FDA Label NDC 85323-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Xuzhou Lanting Pharmaceutical Co., Ltd for the product 4% Lidocaine Pain Relief Patch (NDC 85323-002). 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 4% lidocaine pain relief patch, package ndc code: 85323-002-00, active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ 4% Lidocaine Pain Relief Patch, Package Ndc Code: 85323-002-00

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Directions

→ Other Information

→ Inactive Ingredients

→ Dosage & Administration

→ Otc - Keep Out Of Reach Of Children

4% Lidocaine Pain Relief Patch, Package Ndc Code: 85323-002-00

4% Lidocaine Pain Relief Patch, Package NDC Code: 85323-002-00

Active Ingredient

Active Ingredient: 4% Lidocaine

Purpose

Purpose: Topical anesthetic

Uses

Uses For temporary relief of minor aches & pains of muscles & joints associated with:

simple backache
arthritis
strains
bruises
sprains

Warnings

Warnings (For external use only)

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

When using this product

use only as directed
aviod contact with the eyes, mucous membranes or rashes
donot bandage tightly

Stop use and ask a doctor if

localized skin reactions occur, such as reash, itching, redness, irritation, pain, swelling and blishtering
condition 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 swllowed, get medical help or contact a Poison Control Center right away.

Directions

Uses For temporary relief of minor aches & pains of muscles & joints associated with:

simple backache
arthritis
strains
bruises
sprains

Adult and children 12 years of age and over:

clean and dry affected area
remove film from patch and apply to the skin (see illustration)
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 12 years of age: consult a doctor

Other Information

Avoid storing product in direct sunlight
Protect product from excessive moisture

Inactive Ingredients

Glycerin, dihydroxyaluminum aminoacetate anhydrous, edetate disodium, tartaric acid, povidone K90, dmdm hydantoin, polysorbate 80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate, water.

Dosage & Administration