DR SABHARWALS- lidocaine 4% and menthol 1% patch patch

Dr Sabharwals by

Drug Labeling and Warnings

Dr Sabharwals by is a Otc medication manufactured, distributed, or labeled by Dr. Sabharwal's Wound Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4%

Menthol 1%

PURPOSE

Topical Anesthetic

INTENDED USE OF THE DEVICE

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

WARNINGS

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

• 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.

ASK 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

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

INSTRUCTIONS FOR USE

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 INGREDIENT

Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

QUESTIONS

Call +91-905-677-0088

DOSAGE & ADMINISTRATION

Topical Patch for external use only

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR SABHARWALS 
lidocaine 4% and menthol 1% patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71318-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	224 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	56 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
KAOLIN (UNII: 24H4NWX5CO)
SORBITOL (UNII: 506T60A25R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
CARBOMER 940 (UNII: 4Q93RCW27E)
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

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: 71318-115-15	15 in 1 CARTON	01/30/2024
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 Drug	M017	01/30/2024

Labeler - Dr. Sabharwal's Wound Care (862184668)

Registrant - Dr. Sabharwal's Wound Care (862184668)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Sabharwal's Wound Care		862184668	manufacture(71318-115)