PAIN RELIEF 4% LIDOCAINE DRY PATCH- lidocaine patch

Pain Relief 4% Lidocaine Dry Patch by

Drug Labeling and Warnings

Pain Relief 4% Lidocaine Dry Patch by is a Otc medication manufactured, distributed, or labeled by SAFREL PHARMACEUTICALS, LLC, DR. SABHARWAL'S WOUND CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warning

For external use only

Do not Use

• more than 1 patch on your body at a time or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

When Using This Product

• use only as directed. Read and follow all directions and warnings on this label.
• do not allow contact with the eyes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• do not use at the same time as other topical analgesics
• dispose of used patch in manner that always keeps product away from children or 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 and Pets

• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

• clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
• carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
• once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
• use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

aluminum silicate, butylated hydroxytoluene, silicon dioxide, mineral oil, rosin, polyisobutylene (1000 mw), styrene/isoprene/styrene block copolymer, titanium dioxide, .alpha.-tocopherol acetate

Package / Principle Label

Package / Inner Pouch

INGREDIENTS AND APPEARANCE

PAIN RELIEF 4% LIDOCAINE DRY PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71309-911
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MINERAL OIL (UNII: T5L8T28FGP)
ROSIN (UNII: 88S87KL877)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71309-911-15	15 in 1 BOX	03/15/2022
1		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 final	part348	03/15/2022

Labeler - SAFREL PHARMACEUTICALS, LLC (080566287)

Registrant - SAFREL PHARMACEUTICALS, LLC (080566287)

Establishment
Name	Address	ID/FEI	Business Operations
DR. SABHARWAL'S WOUND CARE		862184668	manufacture(71309-911)