COLD AND HEAT LIDOCAINE PATCH PLUS MENTHOL- lidocaine, menthol patch

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

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Active ingredient:
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Walgreen Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Anesthetic Temporary relief of minor pain
Authorization status:
OTC monograph not final
Authorization number:
0363-0914-05

COLD AND HEAT LIDOCAINE PATCH PLUS MENTHOL- lidocaine, menthol patch

Walgreen 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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Cold and Heat Lidocaine Patch Plus Menthol

Drug Facts

Lidocaine 4% Topical Anesthetic

Menthol 1% Topical Anesthetic

Topical Anesthetic

USES

Temporary relief of minor pain

WARNINGS

For External use only. Use only as directed.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

right away.

■ More than one patch on your body at a time

■ 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 ingredients

■ If pouch is damaged or opened.

If pregnant or breast feeding

Contact a physician prior to use.

WHEN USING:

■ 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.

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.

DIRECTIONS Adults and children 12 years of age and over:

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side

of patch to affected area. Use one patch for up to 12 hours. Discard after single use.

Children under 12 years of age: consult a physician.

INACTIVE INGREDIENTS

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene

glycol,

propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

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

Lidocaine + Menthol Patch

DIST. BY

WALGREEN CO.

200 WILMOT RD.

DEERFIELD, IL 60015

www.walgreens.com

COLD AND HEAT LIDOCAINE PATCH PLUS MENTHOL

lidocaine, menthol patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 9 14

Route of Administration

TOPICAL

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 g in 10 0 g

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL -

UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED

FORM

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

DIHYDRO XYALUMINUM AMINO ACETATE ANHYDRO US (UNII: 1K713C6 15K)

GLYCERIN (UNII: PDC6 A3C0 OX)

KAO LIN (UNII: 24H4NWX5CO)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO LYACRYLIC ACID ( 2 50 0 0 0 MW) (UNII: 9 G2MAD7J6 W)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Walgreen Company

PRO PYLENE GLYCO L 1-( 2 -METHYLBUTYRATE) (UNII: 9 Q5W5G6 46 1)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

SO DIUM PO LYACRYLATE ( 2 50 0 0 0 0 MW) (UNII: 0 5I15JNI2J)

TARTARIC ACID (UNII: W48 8 8 I119 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 36 3-

0 9 14-0 5

5 in 1 POUCH

0 7/0 1/20 18

1

8 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System

(syringe, patch, etc.)

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 7/0 1/20 18

Labeler -

Walgreen Company (008965063)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Fo shan Aqua Gel Bio tech Co .,Ltd.

529 128 76 3

ma nufa c ture (0 36 3-0 9 14)

Revised: 12/2017

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