Pain Patch Perfecto 24 Hours Lidocaine 4% Patch

Pain Patch Perfecto 24 Hours Lidocaine 4% Patch
SPL v2
SPL
SPL Set ID a281c3e9-1c48-4905-98cc-3cedf6042adc
Route
TOPICAL
Published
Effective Date 2024-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-12

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Use

For the temporary relief of minor pain.

Section 50565-1

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).

Section 53414-9

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

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. Do not expose area to heat.

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

• With any other topical anesthetic

• For more than one week without consulting a doctor

• With a heating pad

• If pouch is damaged or opened.

Questions ?

Customer Care Help Line 866-295-5889 Monday - Friday 8:30 a.m. - 4:30 p.m. PST

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, silicon-coated polyester film and styrene isoprene styrene block copolymer.

When Using This Product

• Do not allow 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 contains the drug product that can produce serious adverse effect if child or pet chews or ingest 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 occur such as rash, pain, itching, redness, irritation, swelling or blistering where the product was applied.

Carton Label Ndc 83184 221 01


Structured Label Content

Use

For the temporary relief of minor pain.

Section 50565-1 (50565-1)

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).

Section 53414-9 (53414-9)

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

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. Do not expose area to heat.

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

• With any other topical anesthetic

• For more than one week without consulting a doctor

• With a heating pad

• If pouch is damaged or opened.

Questions ?

Customer Care Help Line 866-295-5889 Monday - Friday 8:30 a.m. - 4:30 p.m. PST

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

Alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.

When Using This Product (When using this product)

• Do not allow 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 contains the drug product that can produce serious adverse effect if child or pet chews or ingest 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 occur such as rash, pain, itching, redness, irritation, swelling or blistering where the product was applied.

Carton Label Ndc 83184 221 01 (Carton Label NDC 83184-221-01)


Advanced Ingredient Data


Raw Label Data

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