2f247929-6bff-1e59-e063-6394a90acdba

SPL v1
SPL
SPL Set ID 2f247929-6bff-1e59-e063-6394a90acdba
Route
topical
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (49.6 mg)
Inactive Ingredients
polyquaternium-7

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-02-28

Description

DRUG FACTS


Medication Information

Warnings and Precautions

For exteral use only

Active Ingredient

Lidocaine 4%

Indications and Usage

Temporarily relieves minor pain

Dosage and Administration

Adults and children 12 years of age and over:

- Clean and dry the affected area.

- Carefully remove the backing from the patch starting at the corner

- Apply the sticky side of the patch to the affected area.

- Use one patch for up to 8 hours.

- Discard the patch after a single use.

- Chindren under 12 years of age: Consult a physician before use

Description

DRUG FACTS

Section 42229-5

DRUG FACTS

Section 50565-1

If swallowed, get medical help or contact a poison Control Center

(1-800-222-1222) immediately.

Section 50566-9

- Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling, or blistering.

- conditions worsen.

- Symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7

- Use only as directed

- Read and follow all directions and warning on this carton

- Avoid contact with the eyes, mucous membranes, or rashes.

- Do not use at the same time as other topical analgesics.

- Do not bandage tightly or apply local heat (such as heating pads) to the area of use.

- Do not microwave.

- Dispose of used patches in a manner that always keeps the product away from children and pets.

- Used patches still contain the drug and could produce serious adverse effects if a child or pet chews or ingests them.

Section 50570-1

- on cut, irritated, or swollen skin. - On puncture wounds. - For more than one week without consulting a doctor. -If you are allergic to any active or inactive ingredient. - If the pouch is damaged or opened.

Section 51727-6

Acrylic block co-polymer adhesve

Section 51945-4

meijer

NDC 79481-3700-1

Lidocain

Pain-Relief

Patches

4% LIDOCAINE TOPICAL ANESTHETIC MAXIMUM STRENGTH

Scissor Trim to Any Size or Shape

Water-Resistant

Uncented

6

Medicated Bandages

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Anesthetic

Section 60561-8

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.


Structured Label Content

Warnings and Precautions (34071-1)

For exteral use only

Active Ingredient (55106-9)

Lidocaine 4%

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 the affected area.

- Carefully remove the backing from the patch starting at the corner

- Apply the sticky side of the patch to the affected area.

- Use one patch for up to 8 hours.

- Discard the patch after a single use.

- Chindren under 12 years of age: Consult a physician before use

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison Control Center

(1-800-222-1222) immediately.

Section 50566-9 (50566-9)

- Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling, or blistering.

- conditions worsen.

- Symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7 (50567-7)

- Use only as directed

- Read and follow all directions and warning on this carton

- Avoid contact with the eyes, mucous membranes, or rashes.

- Do not use at the same time as other topical analgesics.

- Do not bandage tightly or apply local heat (such as heating pads) to the area of use.

- Do not microwave.

- Dispose of used patches in a manner that always keeps the product away from children and pets.

- Used patches still contain the drug and could produce serious adverse effects if a child or pet chews or ingests them.

Section 50570-1 (50570-1)

- on cut, irritated, or swollen skin. - On puncture wounds. - For more than one week without consulting a doctor. -If you are allergic to any active or inactive ingredient. - If the pouch is damaged or opened.

Section 51727-6 (51727-6)

Acrylic block co-polymer adhesve

Section 51945-4 (51945-4)

meijer

NDC 79481-3700-1

Lidocain

Pain-Relief

Patches

4% LIDOCAINE TOPICAL ANESTHETIC MAXIMUM STRENGTH

Scissor Trim to Any Size or Shape

Water-Resistant

Uncented

6

Medicated Bandages

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Anesthetic

Section 60561-8 (60561-8)

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.


Advanced Ingredient Data


Raw Label Data

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