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

Purpose

Pain Relief

Description

Lidocaine 4%


Medication Information

Warnings

For external use only

Purpose

Pain Relief

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

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

Description

Lidocaine 4%

Principal Display Panel

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

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

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%

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

Warnings

For external use only

Purpose

Pain Relief

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

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)

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

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

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%

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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