LIDOCAINE- lidocaine patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Available from:
Kroger Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical anesthetic For temporary relief of pain
Authorization status:
OTC monograph not final
Authorization number:
30142-697-91

LIDOCAINE- lidocaine patch

Kroger Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kroger Co. Lidocaine Patch Drug Facts

Active ingredient

Lidocaine 4%

Purpos e

Topical anesthetic

Us es

For temporary relief of pain

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before 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

use only as directed

avoid contact with the eyes, mucous membranes or rashes

do not bandage tightly

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

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:

Children under 12 years of age: consult a doctor

Other information

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)

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

avoid storing product in direct sunlight

protect product from excessive moisture

store at 20-25°C (68-77°F)

LIDOCAINE

lidocaine patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:30 142-6 9 7

Route of Administration

TOPICAL, PERCUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

4 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

DIHYDRO XYALUMINUM AMINO ACETATE (UNII: DO250 MG0 W6 )

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

KAO LIN (UNII: 24H4NWX5CO)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

Kroger Company

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

TARTARIC ACID (UNII: W48 8 8 I119 H)

UREA (UNII: 8 W8 T178 47W)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:30 142-6 9 7-9 1

6 in 1 CARTON

0 5/17/20 19

1

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 5/17/20 19

Labeler -

Kroger Company (006999528)

Revised: 5/2019

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