Signature Care Medicated Pain Relief Patch

Signature Care Medicated Pain Relief Patch
SPL v4
SPL
SPL Set ID 2165a342-5f8b-78e0-e063-6394a90a06c4
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Glycerin Kaolin Polyethylene Glycol 400 Povidone Ethylhexylglycerin Carboxymethylcellulose Sodium Phenoxyethanol Petrolatum Dihydroxyaluminum Aminoacetate Titanium Dioxide Water Sodium Polyacrylate (8000 Mw) Tartaric Acid Iodopropynyl Butylcarbamate Polyacrylic Acid (8000 Mw) Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Lidocaine

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine

Use

For temporary relief of pain

Section 51945-4

Warning

For external use

Directions

■Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use ■Children under 12 years of age: consult a physician.

Do Not Use

■ More than one patch on your body at a time ■On cut, irritated or swollen skin ■On puncture wounds ■Over raw surfaces or blistered areas ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients■ If pouch is damaged or opened.

Active Ingredient

Lidocaine

Other Information

Other information

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

Inactive Ingredients



aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

When Using This Product

■Use only as directed■Read and follow all directions and warnings 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 or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■Dispose of used patch in manner that always keeps product away from children and pets.

Used patches still contain the drug product that can produce serious adverse effects if a chIld or pet chews or ingests this patch.

If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Consult A Doctor If

■ Condition worsens ■ Redness is present ■ Irritation 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.

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Use

For temporary relief of pain

Section 51945-4 (51945-4)

Purpose

Topical anesthetic

Warning

For external use

Directions

■Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use ■Children under 12 years of age: consult a physician.

Do Not Use (Do not use)

■ More than one patch on your body at a time ■On cut, irritated or swollen skin ■On puncture wounds ■Over raw surfaces or blistered areas ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients■ If pouch is damaged or opened.

Active Ingredient

Lidocaine

Other Information (Other information)

Other information

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

Inactive Ingredients (Inactive ingredients)



aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

When Using This Product (When using this product)

■Use only as directed■Read and follow all directions and warnings 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 or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■Dispose of used patch in manner that always keeps product away from children and pets.

Used patches still contain the drug product that can produce serious adverse effects if a chIld or pet chews or ingests this patch.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

■ Condition worsens ■ Redness is present ■ Irritation 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.

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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