PAIN RELIEF 4% LIDOCAINE- lidocaine patch

Pain Relief 4% Lidocaine by

Drug Labeling and Warnings

Pain Relief 4% Lidocaine by is a Otc medication manufactured, distributed, or labeled by Unexo Life Sciences Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine 4.0%

Purpose

Topical anesthetic

Uses

Temporarily relieves minor pain.

Warnings

For external use only

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.

When using this product

• Use only as directed
• Read and follow all directions and warnings on this pack
• 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 ask 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

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 (1-800-222-1222) right away.

Directions

Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use

• Children 12 years of age or younger: Consult a physician.

Other Information

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

Inactive Ingredients

aluminum glycinate, benzyl alcohol, ethylhexylglycerin, glycerin, kaolin, methylparaben, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or Comments

Call +91 9212228401

SPL UNCLASSIFIED SECTION

Manufactured By:

UNEXO LIFE SCIENCES PVT. LTD.
B-16. Sector 4, Bawana Industrial Area,
Delhi – 110039 (INDIA)

PRINCIPAL DISPLAY PANEL - One Patch Pouch

NDC: 71391-151-01

PAIN RELIEF
4% LIDOCAINE PATCH

Desensitizes aggravated nerves
and relieves pain

No-mess
Single-use application
Easy to apply and remove
Stay-put flexible gel patch
Unscented

1 PATCH
3.93 X 5.51 IN
(10cm X 14cm)

INGREDIENTS AND APPEARANCE

PAIN RELIEF 4% LIDOCAINE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71391-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	344 mg

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
Benzyl Alcohol (UNII: LKG8494WBH)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Kaolin (UNII: 24H4NWX5CO)
Phenoxyethanol (UNII: HIE492ZZ3T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
Tartaric Acid (UNII: W4888I119H)
Titanium Dioxide (UNII: 15FIX9V2JP)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71391-151-01	1 in 1 POUCH; Type 0: Not a Combination Product	08/15/2022
2	NDC: 71391-151-05	5 in 1 BOX	08/15/2022
2	NDC: 71391-151-01	1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 71391-151-06	6 in 1 BOX	08/15/2022
3	NDC: 71391-151-01	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	08/15/2022

Labeler - Unexo Life Sciences Private Limited (872260479)

Establishment
Name	Address	ID/FEI	Business Operations
Unexo Life Sciences Private Limited		872260479	MANUFACTURE(71391-151)