Lidocaine 4% Pain Relief Patch

Lidocaine 4% Pain Relief Patch
SPL v1
SPL
SPL Set ID 19c69983-4e78-8ec5-e063-6394a90a84be
Route
TOPICAL
Published
Effective Date 2024-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Hydrogenated C6-20 Polyolefin (100 Cst) Styrene/isoprene/styrene Block Copolymer (styrene/isoprene 15/85) Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-04

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Uses

For the temporary relief of minor pain.

Section 42229-5

Read directions and warning before use

KEEP OUT OF REACH OF CHILDREN AND PETS

Made in USA from Domestic and Imported Components

Distributed by:

Bionpharma Inc.

Princeton, NJ

08540

L0000735

R0623

Warnings

For external use only.

Directions

■ Adults and children 12 years of age and over: Clean and dry affected area ■ Apply immediately upon removal from pouch ■ Peel off

the first liner and apply exposed patch to affected area ■ Peel off second liner while applying the rest of patch ■ Remove patch after

24 hours ■ Discard patch after single use.

■ Children under 12 years of age: Consult a doctor.

Do Not Use

■ If you are allergic to any active or inactive ingredients of this product ■ On wounds or damaged, irritated or sensitive skin

■ More than one patch on your body at a time or with other topical analgesics at the same time

■ For more than one week without consulting a doctor ■ With a heating pad ■ If pouch is damaged or opened.

Carton Label

NDC 69452-409-04

maximum strength

a+ health TM

pain relief

lidocaine 4% patch

topical analgesic

• desensitizes aggravated nerves

• odor free, thin & flexible

• no-mess, single use application

24 hours

6 Patches

2.91" x 2.17"

Active Ingredient

Lidocaine 4%

Other Information

Store in a clean, dry place away from direct sunlight. Store in original unopened pouch protected from moisture.

Inactive Ingredients

alicyclic hydrocarbon resin, mineral oil, polyester film, silicone-coated polyester film, styrene isoprene, styrene block copolymer.

Questions Or Comments?

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

When Using This Product

■ Avoid contact with the eyes ■ Use only as directed ■ Read and follow all directions and warnings on this

package ■ Do not bandage tightly or apply local heat to the area of use ■ Do not reuse patch ■ Keep this product away from pets and

children. Used patches still contain the drug product that can produce serious adverse effect if a child or pet chews or ingests this

patch

Stop Use and Ask A Doctor If

■ Condition worsens ■ Symptoms persist for more than seven days or clear up and occur again within a

few days ■ Localized skin reactions such as rash, pain, itching, redness, irritation, swelling or blistering occur where the product was

applied.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children and Pets

If chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).


Structured Label Content

Uses

For the temporary relief of minor pain.

Section 42229-5 (42229-5)

Read directions and warning before use

KEEP OUT OF REACH OF CHILDREN AND PETS

Made in USA from Domestic and Imported Components

Distributed by:

Bionpharma Inc.

Princeton, NJ

08540

L0000735

R0623

Purpose

Topical anesthetic

Warnings

For external use only.

Directions

■ Adults and children 12 years of age and over: Clean and dry affected area ■ Apply immediately upon removal from pouch ■ Peel off

the first liner and apply exposed patch to affected area ■ Peel off second liner while applying the rest of patch ■ Remove patch after

24 hours ■ Discard patch after single use.

■ Children under 12 years of age: Consult a doctor.

Do Not Use (Do not use)

■ If you are allergic to any active or inactive ingredients of this product ■ On wounds or damaged, irritated or sensitive skin

■ More than one patch on your body at a time or with other topical analgesics at the same time

■ For more than one week without consulting a doctor ■ With a heating pad ■ If pouch is damaged or opened.

Carton Label

NDC 69452-409-04

maximum strength

a+ health TM

pain relief

lidocaine 4% patch

topical analgesic

• desensitizes aggravated nerves

• odor free, thin & flexible

• no-mess, single use application

24 hours

6 Patches

2.91" x 2.17"

Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)

Store in a clean, dry place away from direct sunlight. Store in original unopened pouch protected from moisture.

Inactive Ingredients (Inactive ingredients)

alicyclic hydrocarbon resin, mineral oil, polyester film, silicone-coated polyester film, styrene isoprene, styrene block copolymer.

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

When Using This Product (When using this product)

■ Avoid contact with the eyes ■ Use only as directed ■ Read and follow all directions and warnings on this

package ■ Do not bandage tightly or apply local heat to the area of use ■ Do not reuse patch ■ Keep this product away from pets and

children. Used patches still contain the drug product that can produce serious adverse effect if a child or pet chews or ingests this

patch

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ Condition worsens ■ Symptoms persist for more than seven days or clear up and occur again within a

few days ■ Localized skin reactions such as rash, pain, itching, redness, irritation, swelling or blistering occur where the product was

applied.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

If chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).


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