85839-011 4% Lidocaine Maximum Strength Pain Relief

85839-011 4% Lidocaine Maximum Strength Pain Relief
SPL v2
SPL
SPL Set ID 3e5a5165-a773-0501-e063-6294a90ae2f4
Route
TOPICAL
Published
Effective Date 2025-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-09

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Use Temporarily relieves minor paln.

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 patch to affected area. Use one patch for up to 12 hours. Discard patch aftersingle 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 Condition worsens Redness is presentlrritation develops Symptoms persist for more than 7 days or clear up and occur again within a few days You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7

When using this product Use only as directed Read and follow alldirections and warings on this carton Do not allow contact with the eyes Do not use at the same time as other topical analgesics Do not bandage tightly orapply local heat (such as heating pads) to the area of use Dispose of usedpatch inmanner that always keeps product away from children and pets. Usedpatches stil contain the drug product that can produce serious adverse effects ifa child or pet chews or ingests this patch.

Section 50570-1

Do not use More than one patch on your body at a time On cut, initated orswollen skin On puncture wounds For more than one week without consultinga doctor lf you are allergic to any active or inactive ingredients lf pouch isdamaged 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)

Use Temporarily relieves minor paln.

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 patch to affected area. Use one patch for up to 12 hours. Discard patch aftersingle 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 Condition worsens Redness is presentlrritation develops Symptoms persist for more than 7 days or clear up and occur again within a few days You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7 (50567-7)

When using this product Use only as directed Read and follow alldirections and warings on this carton Do not allow contact with the eyes Do not use at the same time as other topical analgesics Do not bandage tightly orapply local heat (such as heating pads) to the area of use Dispose of usedpatch inmanner that always keeps product away from children and pets. Usedpatches stil contain the drug product that can produce serious adverse effects ifa child or pet chews or ingests this patch.

Section 50570-1 (50570-1)

Do not use More than one patch on your body at a time On cut, initated orswollen skin On puncture wounds For more than one week without consultinga doctor lf you are allergic to any active or inactive ingredients lf pouch isdamaged 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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