THERUPTOR

Manufacturer
CareNow Medical Pvt Ltd
Effective date
2022-05-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:43

Label at a glance#

ProductTHERUPTOR
Active ingredientALCOHOL
Label structure12 sections

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 again...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

Uses:

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

OTC - QUESTIONS SECTION

Questions or Comments
Call : +19082198175

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80192-195-01

THERUPTOR ®

HandRub-70EA - 100 mL

image descriptionimage description

NDC 80192-196-02

THERUPTOR ®

HandRub-70EA - 125 mL

image descriptionimage description

NDC 80192-199-03

THERUPTOR ®

HandRub-70EA - 200 mL

image descriptionimage description

NDC 80192-197-04

THERUPTOR ®

HandRub-70EA - 500 mL

image descriptionimage description

NDC 80192-200-05

THERUPTOR ®

HandRub-70EA - 1 L

image descriptionimage description

NDC 80192-193-06

THERUPTOR ®

HandRub-70EA - 5 L

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80192-193-062023-07-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-195-012023-07-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-196-022023-07-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-197-042023-07-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-199-032023-07-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-200-052023-07-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-193-062022-02-09C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-195-012022-02-09C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-196-022022-02-09C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-197-042022-02-09C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-199-032022-02-09C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-200-052022-02-09C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-193-062022-01-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-195-012022-01-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-196-022022-01-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-197-042022-01-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-199-032022-01-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA
80192-200-052022-01-28C16284748780-1d6a99b39-af99-a426-e053-dadaa90af4c2THERUPTOR ® HandRub-70EA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80192-193-06THERUPTOR5000 mL in 1 BOTTLESOLUTION50003
80192-195-01THERUPTOR100 mL in 1 BOTTLESOLUTION1003
80192-196-02THERUPTOR125 mL in 1 BOTTLESOLUTION1253
80192-197-04THERUPTOR500 mL in 1 BOTTLESOLUTION5003
80192-199-03THERUPTOR200 mL in 1 BOTTLESOLUTION2003
80192-200-05THERUPTOR1000 mL in 1 BOTTLESOLUTION10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80192-193THERUPTOR (HANDRUB-70EA) SOLUTION [CARENOW MEDICAL PVT LTD]3Legacy NDC, 1 package rows20220527_caeb47cf-a00e-4266-a60a-90380e7cd55a.zip
80192-195THERUPTOR (HANDRUB-70EA) SOLUTION [CARENOW MEDICAL PVT LTD]3Legacy NDC, 1 package rows20220527_caeb47cf-a00e-4266-a60a-90380e7cd55a.zip
80192-196THERUPTOR (HANDRUB-70EA) SOLUTION [CARENOW MEDICAL PVT LTD]3Legacy NDC, 1 package rows20220527_caeb47cf-a00e-4266-a60a-90380e7cd55a.zip
80192-197THERUPTOR (HANDRUB-70EA) SOLUTION [CARENOW MEDICAL PVT LTD]3Legacy NDC, 1 package rows20220527_caeb47cf-a00e-4266-a60a-90380e7cd55a.zip
80192-199THERUPTOR (HANDRUB-70EA) SOLUTION [CARENOW MEDICAL PVT LTD]3Legacy NDC, 1 package rows20220527_caeb47cf-a00e-4266-a60a-90380e7cd55a.zip
80192-200THERUPTOR (HANDRUB-70EA) SOLUTION [CARENOW MEDICAL PVT LTD]3Legacy NDC, 1 package rows20220527_caeb47cf-a00e-4266-a60a-90380e7cd55a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
df6b53b6-d388-5883-e053-2a95a90a1f7bcaeb47cf-a00e-4266-a60a-90380e7cd55a2022-05-20WarningsExact identifier
spl id: df6b53b6-d388-5883-e053-2a95a90a1f7b
spl set id: caeb47cf-a00e-4266-a60a-90380e7cd55a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.