THERUPTOR- handrub-70ea solution

THERUPTOR by

Drug Labeling and Warnings

THERUPTOR by is a Otc medication manufactured, distributed, or labeled by CareNow Medical Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Ethanol (denatured) 70% v/v
Antiseptic Alcohol Topical Solution With Added Moisturizers

Drug Facts

ACTIVE INGREDIENT

Active Ingredient:
Ethanol denatured equivalent to
Ethanol 70% v/v

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

Uses:

• Used for rapid hand disinfection.
• Suitable for use before & after patient contact & in between hand washes

WARNINGS

Warnings:

For external Use only
Flammable. Keep away from heat or flame.

Do not use: In children less than 2 months of age or on open skin wounds. Supervise children under 6 years of age when using this product.

Stop use and ask doctor if irritation or rash occurs, conditions persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of children, If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

• Place enough product on hands to cover all surfaces.
• Rub hands together until dry.

INACTIVE INGREDIENT

Inactive Ingredient:
Brilliant Blue, Glycerine, Fragrance and purified water.

STORAGE AND HANDLING

Other Information:

• Store between 15°-30°C (59°-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Theruptor Handrub-70EA is an antiseptic hand hygiene solution containing Ethanol (denatured), skin emollients and moisturizers. It has a broad spectrum of antimicrobial activity and is an effective viricidal, bactericidal and fungicidal.

Proven Anti-microbial Efficacy - provides rapid bactericidal action against a broad spectrum of micro organisms.

Skin Antiseptic formula with a combination of alcohol and skin emollients for effective bactericidal, fungicidal & Viricidal activity.

Moisturized with skin emollients to prevent skin dryness and damage.

SPL UNCLASSIFIED SECTION

Made in India by
CareNow Medical Pvt Ltd, #3/272-5, Neelambur Rd, Muthugoundenpudur, Coimbatore, TN- 641402
Ph: +91 422 2988949, E: info@carenowindia.com, W: www.carenowindia.com

Mfg.Lic.No: TN00003742

QUESTIONS

Questions or Comments
Call : +19082198175

PRINCIPAL DISPLAY PANEL

NDC: 80192-195-01

THERUPTOR ®

HandRub-70EA - 100 mL

NDC: 80192-196-02

THERUPTOR ®

HandRub-70EA - 125 mL

NDC: 80192-199-03

THERUPTOR ®

HandRub-70EA - 200 mL

NDC: 80192-197-04

THERUPTOR ®

HandRub-70EA - 500 mL

NDC: 80192-200-05

THERUPTOR ®

HandRub-70EA - 1 L

NDC: 80192-193-06

THERUPTOR ®

HandRub-70EA - 5 L

INGREDIENTS AND APPEARANCE

THERUPTOR 
handrub-70ea solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80192-195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80192-195-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020

THERUPTOR 
handrub-70ea solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80192-196
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80192-196-02	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020

THERUPTOR 
handrub-70ea solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80192-199
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80192-199-03	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020

THERUPTOR 
handrub-70ea solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80192-197
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80192-197-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020

THERUPTOR 
handrub-70ea solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80192-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80192-200-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020

THERUPTOR 
handrub-70ea solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80192-193
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80192-193-06	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020

Labeler - CareNow Medical Pvt Ltd (876995708)

Establishment
Name	Address	ID/FEI	Business Operations
CareNow Medical Pvt Ltd		876995708	manufacture(80192-195, 80192-196, 80192-199, 80192-197, 80192-200, 80192-193) , analysis(80192-195, 80192-196, 80192-199, 80192-197, 80192-200, 80192-193) , pack(80192-195, 80192-196, 80192-199, 80192-197, 80192-200, 80192-193)