87125-001 Lidocaine Pain Relieving Gel-patch

87125-001 Lidocaine Pain Relieving Gel-patch
SPL v1
SPL
SPL Set ID 40c9b132-57ce-865e-e063-6394a90a2080
Route
TOPICAL
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Water Phenoxyethanol Polyvinyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-10

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage



Temporarily relieves minor pain

associated with:

arthritis

simple backache

muscle strains

sprains

bruises

Dosage and Administration



Adults and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin

apply one patch at a time to affected area

use 1 patch for up to 8 hours

do not use more than 3 to 4 times daily

Children under 12 years of age: consult

a doctor

Description

Lidocaine 4%

Section 50565-1

Used patches contain a large amount of lidocaine. lf swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).Accidental exposure in children can result in death.

Section 50566-9



condition worsens or symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

severe burning sensation, itching, rash or skin irritation develops

If pregnant or breast-feeding, ask a health professional before use.

Section 50567-7



Use only as directed

Do not bandage tightly

Avoid contact with eyes and mucous membranes

Temporary burning or redness at application site may occur

Rare cases of serlous burns have been reported with products of this type

Section 50570-1



on wounds or damaged, broken or irritated skin

with a heating pad

if you are allergic to any ingredients of this product

Section 51727-6

WATER

POLYVINYL ALCOHOL

PHENOXYETHANOL

Section 51945-4

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)



Temporarily relieves minor pain

associated with:

arthritis

simple backache

muscle strains

sprains

bruises

Dosage and Administration (34068-7)



Adults and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin

apply one patch at a time to affected area

use 1 patch for up to 8 hours

do not use more than 3 to 4 times daily

Children under 12 years of age: consult

a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Used patches contain a large amount of lidocaine. lf swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).Accidental exposure in children can result in death.

Section 50566-9 (50566-9)



condition worsens or symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

severe burning sensation, itching, rash or skin irritation develops

If pregnant or breast-feeding, ask a health professional before use.

Section 50567-7 (50567-7)



Use only as directed

Do not bandage tightly

Avoid contact with eyes and mucous membranes

Temporary burning or redness at application site may occur

Rare cases of serlous burns have been reported with products of this type

Section 50570-1 (50570-1)



on wounds or damaged, broken or irritated skin

with a heating pad

if you are allergic to any ingredients of this product

Section 51727-6 (51727-6)

WATER

POLYVINYL ALCOHOL

PHENOXYETHANOL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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