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

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 55106-9

Lidocaine 4%

Section 60561-8

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


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 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

Warnings and Precautions (34071-1)

For exteral use only

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 55106-9 (55106-9)

Lidocaine 4%

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

All Sections (JSON)