84735-010 4% Lidocaine Patch

84735-010 4% Lidocaine Patch
SPL v3
SPL
SPL Set ID 35a15e60-b33c-5065-e063-6294a90ad9df
Route
TOPICAL
Published
Effective Date 2025-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Aluminum Glycinate Polyacrylic Acid (250000 Mw) Water Aluminum Hydroxide Cellulose Gum Tartaric Acid Titanium Dioxide Dmdm Hydantoin Silica Urea Ricinus Communis (castor) Seed Oil Sodium Polyacrylate (2500000 Mw) Glycerin Polysorbate 80 Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-21

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Use Temperarily relicwes miner pain.

Dosage and Administration

Adults and chldren 12 years of age and over: Clean and dry affected areaCarefully remove backing from patchstarting at a corner. Apply sticky sideof patch to affected area. Use one patch for up to 12 hours. Discard patchaftersingle use. Children under 12 years of age: consult a physician.

Description

Lidocaine 4%

Section 50565-1

Keep out of reach of children and pets.

Section 50566-9

Stop use and consult a doctor if condtion worsensm Redness is presert lniation develops Sympioms persist for more than 7 dlays or clear up and oocuragain willin a ferw darys You coperienoe signs of skin injury, such as pain, sweling or bllslering where the product was applled.

Section 50567-7

When using this product Use only as directed Read and follow all directionsand warings on this carton Do not allow oontact with the oyes Do not use atthe same lime as oler bopical analgesics Do nat bandage lighlly or apoly localheat (such as heating pads, to the area of use Dispose of uged patch inmannerihat always keeps product away irom children and pots, Lised paiches siilcontain the drug product that can produce gerious adverge elfecis if a child or petchaws or ingasis ihis patchh.

Section 50570-1

Do not use More than one patch on your body at a time On gut, initated orswollen gkin On puncture wounds For more than one week without consultinga doctor if you are allergic to any aclive or inactive ingrediantsm lf pouch iscambged or opred.

Section 51727-6

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum (Sodium CMC)

DMDM Hydantoin

Glycerin

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Ricinus Communis (Castor) Seed Oil

Silica (Colloidal)

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Urea

Water (Purified Water)

Section 51945-4

Section 55105-1

Topical Aneslhetic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

Use Temperarily relicwes miner pain.

Dosage and Administration (34068-7)

Adults and chldren 12 years of age and over: Clean and dry affected areaCarefully remove backing from patchstarting at a corner. Apply sticky sideof patch to affected area. Use one patch for up to 12 hours. Discard patchaftersingle use. Children under 12 years of age: consult a physician.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children and pets.

Section 50566-9 (50566-9)

Stop use and consult a doctor if condtion worsensm Redness is presert lniation develops Sympioms persist for more than 7 dlays or clear up and oocuragain willin a ferw darys You coperienoe signs of skin injury, such as pain, sweling or bllslering where the product was applled.

Section 50567-7 (50567-7)

When using this product Use only as directed Read and follow all directionsand warings on this carton Do not allow oontact with the oyes Do not use atthe same lime as oler bopical analgesics Do nat bandage lighlly or apoly localheat (such as heating pads, to the area of use Dispose of uged patch inmannerihat always keeps product away irom children and pots, Lised paiches siilcontain the drug product that can produce gerious adverge elfecis if a child or petchaws or ingasis ihis patchh.

Section 50570-1 (50570-1)

Do not use More than one patch on your body at a time On gut, initated orswollen gkin On puncture wounds For more than one week without consultinga doctor if you are allergic to any aclive or inactive ingrediantsm lf pouch iscambged or opred.

Section 51727-6 (51727-6)

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum (Sodium CMC)

DMDM Hydantoin

Glycerin

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Ricinus Communis (Castor) Seed Oil

Silica (Colloidal)

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Urea

Water (Purified Water)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Aneslhetic

Section 55106-9 (55106-9)

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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