lidocaine by Kroger Company LIDOCAINE patch

lidocaine by

Drug Labeling and Warnings

lidocaine by is a Otc medication manufactured, distributed, or labeled by Kroger Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary relief of pain

Warnings

For external use only

Do not use

• more than 1 patch at a time
• on wounds or damaged skin
• with a heating pad
• if you have ever had an allergic reaction to this product or any of its ingredients

When using this product

• use only as directed
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly

Stop use and ask a doctor if

• localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• conditions 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 over:

• clean and dry affected area
• remove film from patch and apply to the skin (see illustration)
• apply 1 patch at a time to affected area, not more than 3 to 4 times daily
• remove patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a doctor

Other information

• avoid storing product in direct sunlight
• protect product from excessive moisture
• store at 20-25°C (68-77°F)

Inactive ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, tartaric acid, urea

Questions or comments?

1-800-632-6900

Package/Label Principal Display Panel

COMPARE TO the active ingredient of SALONPAS® LIDOCAINE PATCH See back panel.

Maximum Strength

Lidocaine Patch

4% Lidocaine/Topical Anesthetic

For Back, Neck, Knees, Shoulders & Elbows

Up to 8 Hours of Relief

For Temporary Relief of Pain

Desensitize Aggravated Nerves

Numbing Relief

Unscented

6 PATCHES

3 15/16 IN X 5 ½ IN (10cm x 14cm)

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-697
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYVINYL ALCOHOL (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TARTARIC ACID (UNII: W4888I119H)
UREA (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-697-91	6 in 1 CARTON	05/17/2019
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/17/2019

Labeler - Kroger Company (006999528)