DR SABHARWALS- menthol 5% 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

Menthol 5%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Temporarily relieves minor aches and pain of muscles and joints accociated with, simple backache, arthritis, strains, bruises and sprains

WARNINGS

For external use only

DO NOT USE

• more than 1 patch on your body at a time
• on cut, irritated or swollen skin
• on puncture wounds or damaged skin
• for more than one week without consulting a doctor
• with heating pad
• on a child under 12 yeas of age with arthritis-like conditions

WHEN USING

• use only as directed.
• read and follow all directions and warnings on this label
• rare cases of serious burns have been reported with products of this type.
• do not apply to wounds or damaged, broken or irritated skin
• do not allow contact with eyes and mucous membranes
• 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 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
• a transient burning sensation may occur upon application but generally disappears in several days
• if a severe burning sensation occurs, discontinue use immediately.
• discontinue use at least 1 hour before a bath or shower.
• do not use immediately after a bath or shower.

ASK DOCTOR

• condition worsens
• redness is present over the affected area
• excess skin irritation occurs
• 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 pregnanat or breast feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children and pets

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

INSTRUCTIONS FOR USE

Adult and children over 12years:

• Clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle
• carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
• do not wear a patch for more than 8 hours
• apply affected area no more than 3 times daily

children 12 years or younger:

• ask a doctor

STORAGE AND HANDLING

Store at room temperature 20-25 0C (68-77 0F)

QUESTIONS

Call +91-905-677-0088

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.

DOSAGE & ADMINISTRATION

Topical Pain Relief Patch of External Use Only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR SABHARWALS 
menthol 5% patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71318-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	240 mg

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

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: 71318-116-15	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(71318-116)