NIRAVI 24 HOURS LIDOCAINE 4 % PATCH- lidocaine patch

Niravi 24 Hours Lidocaine 4 % Patch by

Drug Labeling and Warnings

Niravi 24 Hours Lidocaine 4 % Patch by is a Otc medication manufactured, distributed, or labeled by Sparsha Pharma USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Use

For the temporary relief of minor pain.

Warnings

For External Use Only

Do not use

If you are allergic to any active or inactive ingredients of this product
On wounds or damaged, irritated or sensitive skin
With any other topical anesthetic
For more than one week without consulting a doctor
With a heating pad
If pouch is damaged or opened.

When using this product

Do not allow contact with the eyes
Use only as directed
Read and follow all directions and warnings on this package
Do not bandage tightly or apply local heat to the area of use
Do not reuse patch
Keep this product away from pets and children. Used patches still contains the drug product that can produce serious adverse effect if child or pet chews or ingest this patch.

Stop use and ask a doctor if

Condition worsens
Symptoms persist for more than seven days or clear up and occur again within a few days
Localized skin reactions occur such as rash, pain, itching, redness, irritation, swelling or blistering where the product was applied.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets. If chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Do not expose area to heat.

Children under 12 years of age: Consult a doctor.

Inactive Ingredients

Alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.

Other information

.Store in a clean, dry place away from direct sunlight. Store in original unopened pouch. protected from moisture.

Questions ?

Customer Care Helpline 844-348-5423 Monday- Friday 8:30 a.m – 4:30 p.m PST

PACKAGE LABEL

Carton Label NDC: 73638-901-01

Pouch Label

INGREDIENTS AND APPEARANCE

NIRAVI 24 HOURS LIDOCAINE 4 % PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73638-901
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
MINERAL OIL (UNII: T5L8T28FGP)
HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73638-901-01	6 in 1 CARTON	06/30/2021
1		1 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	06/30/2021

Labeler - Sparsha Pharma USA, Inc. (079365856)

Registrant - Sparsha Pharma USA, Inc. (079365856)

Establishment
Name	Address	ID/FEI	Business Operations
Sparsha Pharma USA, Inc.		079365856	manufacture(73638-901)