85248-019

85248-019
SPL v1
SPL
SPL Set ID 497e6e18-ba46-0001-e063-6294a90af026
Route
TOPICAL
Published
Effective Date 2026-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Aluminum Hydroxide Polyacrylic Acid (250000 Mw) Titanium Dioxide Sodium Polyacrylate (2500000 Mw) Tartaric Acid Nonoxynol-30 Sorbitan Sesquioleate Polysorbate 80 Cellulose Gum Glycerin Isopropyl Myristate Starch, Corn Talc

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-29

Description

Lidocaine 4%

Purpose

Pain Relief


Medication Information

Purpose

Pain Relief

Description

Lidocaine 4%

Use

▆temporarily relieves minor pain associated with: ▆arthritis ▆simple backache▆bursitis ▆tendonitis ▆muscle strains ▆sprains▆bruises ▆cramps

Stop Use

▆condition worsens ▆redness is present ▆irritation develops▆symptoms persist for more than 7 days or clear up and occur again within a few dsys ▆you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding. ask a health professional before use

Warnings

For external use only

Ask Doctor

▆condition worsens ▆redness is present ▆irritation develops▆symptoms persist for more than 7 days or clear up and occur again within a few dsys ▆you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Directions

adults and children over 12 years. ▆remove backing from patch by firmly grasping both ends and gently pulling until backing separate in middle ▆carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ▆once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ▆Wear one patch for up to 8 hours. ▆Repeat if needed, but do not use more than 3 times daily. children 12 years or younger: ask a doctor

Do Not Use

▆use only as directed. Read and follow all directions and warnings on this carton. ▆avoid contact with eyes and mucous membranes ▆rare cases of serious burns have been reported with products of this type ▆ do not apply to wounds or damaged skin, broken or irritated skin ▆do not bandage tightly or apply local heat (such as heating pads) to the area of use ▆ A transient burning sensation may occur upon application but usually disappears within a few days.

When Using

▆use only as directed. Read and follow all directions and warnings on this carton. ▆avoid contact with eyes and mucous membranes ▆rare cases of serious burns have been reported with products of this type ▆ do not apply to wounds or damaged skin, broken or irritated skin ▆do not bandage tightly or apply local heat (such as heating pads) to the area of use ▆ A transient burning sensation may occur upon application but usually disappears within a few days.

Active Ingredient

Lidocaine 4%

Inactive Ingredients

water, aluminym hvdroxide, cellulose gum, glvcerin, isopropyl myristate, nonoxynol-30, polyacrylic acid,polysorbate 80, sodium polvacrvlate, sorbitan sesauioleate,Starch, talc, tartaric acid,titanium dioxide

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Use

▆temporarily relieves minor pain associated with: ▆arthritis ▆simple backache▆bursitis ▆tendonitis ▆muscle strains ▆sprains▆bruises ▆cramps

Purpose

Pain Relief

Stop Use

▆condition worsens ▆redness is present ▆irritation develops▆symptoms persist for more than 7 days or clear up and occur again within a few dsys ▆you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding. ask a health professional before use

Warnings

For external use only

Ask Doctor

▆condition worsens ▆redness is present ▆irritation develops▆symptoms persist for more than 7 days or clear up and occur again within a few dsys ▆you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Directions

adults and children over 12 years. ▆remove backing from patch by firmly grasping both ends and gently pulling until backing separate in middle ▆carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ▆once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ▆Wear one patch for up to 8 hours. ▆Repeat if needed, but do not use more than 3 times daily. children 12 years or younger: ask a doctor

Do Not Use (Do not use)

▆use only as directed. Read and follow all directions and warnings on this carton. ▆avoid contact with eyes and mucous membranes ▆rare cases of serious burns have been reported with products of this type ▆ do not apply to wounds or damaged skin, broken or irritated skin ▆do not bandage tightly or apply local heat (such as heating pads) to the area of use ▆ A transient burning sensation may occur upon application but usually disappears within a few days.

When Using

▆use only as directed. Read and follow all directions and warnings on this carton. ▆avoid contact with eyes and mucous membranes ▆rare cases of serious burns have been reported with products of this type ▆ do not apply to wounds or damaged skin, broken or irritated skin ▆do not bandage tightly or apply local heat (such as heating pads) to the area of use ▆ A transient burning sensation may occur upon application but usually disappears within a few days.

Active Ingredient

Lidocaine 4%

Inactive Ingredients (Inactive ingredients)

water, aluminym hvdroxide, cellulose gum, glvcerin, isopropyl myristate, nonoxynol-30, polyacrylic acid,polysorbate 80, sodium polvacrvlate, sorbitan sesauioleate,Starch, talc, tartaric acid,titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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