THERA CARE 24HRS LIDOCAINE PATCH- lidocaine 4% patch

THERA CARE 24hrs Lidocaine Patch by

Drug Labeling and Warnings

THERA CARE 24hrs Lidocaine Patch by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Sparsha Pharma USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Purpose

Temporarily relieves minor pain.

Dosage and Administration

Directions Adults and children over 12 years:

■ clean and dry affected area

■ carefully remove backing from patch starting at corner

■ apply sticky side of patch to affected area

■ use one patch for up to 24 hours. Discard patch after single use. Children under 12 years of age: consult a physician.

Warnings

For external use only.

Idications and Usage

Uses: Temporaily relieves minor pains.

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.

Stop use and consult a doctor

■ 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

Do not Use

■ 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.

Keep out of reach of children and pets.

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

Other Safety Information

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

Inactive Ingredients

Styrene Isoprene Styrene block Copolymer, Alicyclic Saturated Hydrocarbon Resin, White Mineral Oil

Questions

TOLL-FREE

Customer Care Help Line
866-326-1313
Mon–Fri 8:30 am–4:30 pm CST

Manufactured For
Veridian Healthcare, LLC
Gurnee, IL 60031

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERA CARE 24HRS LIDOCAINE PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-916
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)
HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-916-06	6 in 1 CARTON	05/01/2018
1		9 g in 1 PATCH; 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	05/01/2018

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Sparsha Pharma USA, Inc.		079365856	manufacture(71101-916)