85839-007 Lidocaine Patch

85839-007 Lidocaine Patch
SPL v1
SPL
SPL Set ID 3875bde5-2e1a-5fdf-e063-6294a90a3c0d
Route
TOPICAL
Published
Effective Date 2025-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-26

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves minor pain

Dosage and Administration



Adults and children 12 years of age and over: Clean and dry affected area.Carefully remove backing from patchstarting at a corner. Apply sticky side of patchto affected area.Use one patch for up to 12 hours. Discard patch aftersingleuse.

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, Condition worsens,Redness is present lrritationdevelops Symptoms persist for more than 7 days or clear up and occur again within afew days You experience signs of skin injury, such as pain, swelling or blistering wherethe product was applied.

Section 50567-7

When using this product Use only as directed Read and follow alldirections and waringson this carton Do not allow contact with the eyes. Do not use at the same time as othertopical analgesics Do not bandage tightly orapply local heat (such as heating pads) to thearea of use Dispose of usedpatch inmanner that always keeps product away from childrenand pets, Used patches stil contain the drug product that can produce serious adverse effectsifa child or pet chews or ingests this patch.

Section 50570-1

More than one patch on your body at a time On cut, initated or swollen skin Onpuncture wounds. For more than one week without consulting a doctor lf you are allergicto any active or inactive ingredients lf pouch is damaged or opened.

Section 51727-6

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum

DMDM hydantoin

Glycerin

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Ricinus Communis Seed Oil (castor)

Silica

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Urea

Water

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

Dosage and Administration (34068-7)



Adults and children 12 years of age and over: Clean and dry affected area.Carefully remove backing from patchstarting at a corner. Apply sticky side of patchto affected area.Use one patch for up to 12 hours. Discard patch aftersingleuse.

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, Condition worsens,Redness is present lrritationdevelops Symptoms persist for more than 7 days or clear up and occur again within afew days You experience signs of skin injury, such as pain, swelling or blistering wherethe product was applied.

Section 50567-7 (50567-7)

When using this product Use only as directed Read and follow alldirections and waringson this carton Do not allow contact with the eyes. Do not use at the same time as othertopical analgesics Do not bandage tightly orapply local heat (such as heating pads) to thearea of use Dispose of usedpatch inmanner that always keeps product away from childrenand pets, Used patches stil contain the drug product that can produce serious adverse effectsifa child or pet chews or ingests this patch.

Section 50570-1 (50570-1)

More than one patch on your body at a time On cut, initated or swollen skin Onpuncture wounds. For more than one week without consulting a doctor lf you are allergicto any active or inactive ingredients lf pouch is damaged or opened.

Section 51727-6 (51727-6)

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum

DMDM hydantoin

Glycerin

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Ricinus Communis Seed Oil (castor)

Silica

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Urea

Water

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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