Label: THERUPTOR- wipes-70ea cloth

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 26, 2022

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  • SPL UNCLASSIFIED SECTION

    70% v/v Ethanol (denatured)

    Alcohol based
    Hand Sanitizing Wipes

  • Drug Facts

  • Active Ingredient:

    Ethanol denatured equivalent to Ethanol 70% v/v

  • Purpose

    Antiseptic

  • Uses:

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

    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.

  • Direction of Use:

    • 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:

    Glycerine, Fragrance and purified water.

    Size of Wipe : 15 x 20cm

  • Other Information:

    • 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

    NDC 80192-208-01

    THERUPTOR ® Wipes-70EA - 70 wipes

    NDC 80192-208-01

    NDC 80192-204-02

    THERUPTOR ® Wipes-70EA - 50 wipes

    NDC 80192-204-02

    NDC 80192-239-03

    THERUPTOR ® Wipes-70EA - 120 wipes

    NDC 80192-239-03

  • INGREDIENTS AND APPEARANCE
    THERUPTOR 
    wipes-70ea cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80192-208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80192-208-0170 in 1 CANISTER09/03/2020
    1490 mL in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/03/2020
    THERUPTOR 
    wipes-70ea cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80192-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80192-204-0250 in 1 PACKAGE09/03/2020
    1350 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/03/2020
    THERUPTOR 
    wipes-70ea cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80192-239
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80192-239-03120 in 1 CANISTER01/24/2022
    1840 mL in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/24/2022
    Labeler - CareNow Medical Pvt Ltd (876995708)
    Establishment
    NameAddressID/FEIBusiness Operations
    CareNow Medical Pvt Ltd876995708manufacture(80192-208, 80192-204, 80192-239) , analysis(80192-208, 80192-204, 80192-239) , pack(80192-208, 80192-204, 80192-239)
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