PAIN RELIVEING PATCH- lidocaine 4% patch

Pain Reliveing Patch by

Drug Labeling and Warnings

Pain Reliveing Patch by is a Otc medication manufactured, distributed, or labeled by simple diagnostics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

LIDOCAINE PATCH 4%

Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

USE

For the temporary relief of pain

Warnings

For external use only

Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds
for more than one week without consulting a doctor

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 bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics
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.

DO NOT USE:

• More than 1 patch at a time
• On wounds or damaged skin
• For more than one week without consulting a doctor
• If you are allergic to any ingredients of this product

STOP USE AND ASK A DOCTOR IF:

• Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Condition worsen
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days

IF PREGNANT OR BREAST-FEEDING:

Ask a health professional before use

Keep out of reach of children

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

Directions

Adults and children 12 years of age and older:
Wash and dry the affected area.
Peel off the backing film from one side of the patch carefully
Apply the exposed portion of the patch to the affected area.
Gently press the patch with your hand to fit the affected area completely.
Do not exercise vigorously during use to prevent the patch from falling off.
Use only 1 patch for a maximum of 8 hours.
Children under 12 years of age: Ask a doctor before use.

QUESTIONS OR COMMENTS:

• Customerservice@simplediagnostics.com
• 877-342-2385
  

Other information

• Store at room temperature 15°-30°C (59°-86°F)
• Store in a cool dry place away from direct sunlight

Inactive ingredient

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Povidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL:

INGREDIENTS AND APPEARANCE

PAIN RELIVEING PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62379-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.4 g

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POVIDONE K90 (UNII: RDH86HJV5Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62379-201-03	30 in 1 CASE	06/01/2023
1	NDC: 62379-201-02	5 in 1 BOX
1	NDC: 62379-201-01	1 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/01/2023

Labeler - simple diagnostics (004135503)