Label: SOFT CARE FOAM INSTANT HAND SANITIZER- alcohol liquid

  • NDC Code(s): 64536-7295-4, 64536-7295-5
  • Packager: Diversey, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 16, 2019

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl alcohol 62% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses:

    For hands to decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    Do not ingest

    Do not use in the eyes.

    When using this product do not get into the eyes.

    In case of contact, immediately flush with water.

    Stop use and ask a doctor if irritation or redness develop.

    If condition persists for more than 72 hours, consult a doctor.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Apply 1-2 ml into hands, rub product vigorously over hands covering all surfaces.

    Allow to air dry - do not rinse.

  • REFERENCES

    Other information:

    EMERGENCY PHONE: 1-800-851-7145

    See SDS MS0301383

    Store below 35 C (95 F)

    See container for Lot Code and Expiry Date

    Do not contaminate water, food or feed during use, storage or disposal.

    For Commercial and Industrial Use Only

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbabensis Leaf Juice, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    container label 532DL2container label 50DL2

    NDC 64536-7295-4

    Diversey

    SoftCare

    Foam Instant

    Hand Sanitizer

    Kills 99.9% of germs and bacteria

    Aloe and Vitamin E to moisturize

    Contains alcohol

    Clean

    Protect

    Refresh

    Net Contents

    532 mL/1.12 U.S. Pt.

    SKU: 100930835

  • INGREDIENTS AND APPEARANCE
    SOFT CARE FOAM INSTANT HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64536-7295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64536-7295-550 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
    2NDC:64536-7295-4532 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/03/2016
    Labeler - Diversey, Inc. (018240817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture(64536-7295)
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