FDA.reportPublic FDA data

THERUPTOR

Manufacturer
CareNow Medical Pvt Ltd
Effective date
2022-05-26
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

Indications and uses

Indicated for rapid hand disinfection and sanitization. Recommended for repeated use.

Storage and handling

Store below 110°F (43°C) 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

70% v/v Ethanol (denatured)

Alcohol based
Hand Sanitizing Wipes

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Ethanol denatured equivalent to Ethanol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

  • Indicated for rapid hand disinfection and sanitization.
  • Recommended for repeated use.

Warnings:

WARNINGS SECTION

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.

OTC - STOP USE SECTION

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.

Direction of Use:

DOSAGE & ADMINISTRATION SECTION

  • Open the canister cap and pull a wipe
  • Keep package tightly closed.
  • Wet hands thoroughly with product and allow to dry.
  • Residual alcohol should be emptied prior to disposing.
  • Dispose wipes and package in accordance with local regulation
  • Once opened, keep canister tightly closed.

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Glycerine, Fragrance and purified water.

Size of Wipe : 15 x 20cm

Other Information:

STORAGE AND HANDLING SECTION

  • Store below 110°F (43°C)

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 or Comments
Call : + 19082198175

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80192-208-01

THERUPTOR ® Wipes-70EA - 70 wipes

NDC 80192-208-01NDC 80192-208-01

NDC 80192-204-02

THERUPTOR ® Wipes-70EA - 50 wipes

NDC 80192-204-02NDC 80192-204-02

NDC 80192-239-03

THERUPTOR ® Wipes-70EA - 120 wipes

NDC 80192-239-03NDC 80192-239-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN3
1489307ethanol 0.7 ML/ML Medicated PadSCD3
1489307ethanol 70 % Medicated PadSY3
1489307ethanol 70 % Medicated WipesSY3
1489307ethyl alcohol 70 % ClothSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80192-204-022023-07-28C16284748780-1d6a99b39-6189-a426-e053-dadaa90af4c2THERUPTOR ® Wipes-70EA
80192-208-012023-07-28C16284748780-1d6a99b39-6189-a426-e053-dadaa90af4c2THERUPTOR ® Wipes-70EA
80192-239-032023-07-28C16284748780-1d6a99b39-6189-a426-e053-dadaa90af4c2THERUPTOR ® Wipes-70EA
80192-204-022022-02-09C16284748780-1d6a99b39-6189-a426-e053-dadaa90af4c2THERUPTOR ® Wipes-70EA
80192-208-012022-02-09C16284748780-1d6a99b39-6189-a426-e053-dadaa90af4c2THERUPTOR ® Wipes-70EA
80192-204-022022-01-28C16284748780-1d6a99b39-6189-a426-e053-dadaa90af4c2THERUPTOR ® Wipes-70EA
80192-208-012022-01-28C16284748780-1d6a99b39-6189-a426-e053-dadaa90af4c2THERUPTOR ® Wipes-70EA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80192-204-02THERUPTOR50 in 1 PACKAGECLOTH503
80192-204-02THERUPTOR350 mL in 1 PACKAGECLOTH3503
80192-208-01THERUPTOR70 in 1 CANISTERCLOTH703
80192-208-01THERUPTOR490 mL in 1 CANISTERCLOTH4903
80192-239-03THERUPTOR840 mL in 1 CANISTERCLOTH8403
80192-239-03THERUPTOR120 in 1 CANISTERCLOTH1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80192-204THERUPTOR (WIPES-70EA) CLOTH [CARENOW MEDICAL PVT LTD]3Legacy NDC, 2 package rows20220527_d2dcfdcf-efa4-4158-92b9-aed26fe798ac.zip
80192-208THERUPTOR (WIPES-70EA) CLOTH [CARENOW MEDICAL PVT LTD]3Legacy NDC, 2 package rows20220527_d2dcfdcf-efa4-4158-92b9-aed26fe798ac.zip
80192-239THERUPTOR (WIPES-70EA) CLOTH [CARENOW MEDICAL PVT LTD]3Legacy NDC, 2 package rows20220527_d2dcfdcf-efa4-4158-92b9-aed26fe798ac.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80192-20880192-208-01
80192-20480192-204-02
80192-23980192-239-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
dfec15c0-ebce-246a-e053-2a95a90ad478d2dcfdcf-efa4-4158-92b9-aed26fe798ac2022-05-26WarningsExact identifier
spl id: dfec15c0-ebce-246a-e053-2a95a90ad478
spl set id: d2dcfdcf-efa4-4158-92b9-aed26fe798ac

Reported adverse events (FAERS/openFDA)#

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