Label: HAND SANITIZER SMELLS CLEAN- ethanol gel

  • 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 2, 2020

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  • HAND SANITIZER

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.00% v/v).
    3. Phenoxyethanol and chlorphenesin (0.3% v/v).
    4. Sterile distilled water or boiled cold water.

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

    Phenoxyethanol (and) chlorphenesin: 0.3%

  • Purpose

    Antiseptic, Hand Sanitizer

    To help reduce bacteria on the skin that could cause disease.

  • Indications and Usage

    Apply enough hand Sanitizer to cover all hands surface
    Rub hands palm to palm
    Right palm over left dorsum with interfaced fingers and vice versa.
    Palm to palm with fingers interfaced.
    Backs of fingers to opposing palms with fingers interlocked.
    Rotational rubbing of left thumbs clasped in right palmed and vice versa.
    Rotational rubbing backwards and forwards with clasped fingers of right hand and left palm and vice versa.
    And your hands are disinfected.

  • Warnings

    Flammable. Keep away from fire or flame

    For external use only.

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

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

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Other information

    • Store between 15-30C (59-86F)
    • May discolor certain fabrics or surfaces.

  • Inactive ingredients

    Water, glycerin, Carbomer,DMDM Hydantoin, Triethanolamine

  • Package Label - Principal Display Panel

    Hand Sanitizer

    moisturizes+sanitizes+gel

    Hand Sanitizer- 500 ML

    Hand Sanitizer

    moisturizes+sanitizes+gel

    16.9 fl. oz (500 mL) NDC: 75525-001-50

    HS Label 500 ML

    HAND SANITIZER 60 ML

    Hand Sanitizer

    moisturizes+sanitizes+gel

    2.02 fl. oz (60 mL) NDC: 75525-001-06

    HS LABEL 60 ML

    HAND SANITIZER 1000 ML

    Hand Sanitizer

    moisturizes+sanitizes+gel

    33.8 fl. oz (1000 mL) NDC: 75525-001-10

    HS LABEL 1000 ML

    HAND SANITIZER 2000 ML

    Hand Sanitizer

    moisturizes+sanitizes+gel

    67.6 fl. oz (2000 mL) NDC: 75525-001-20

    HS LABEL 2000 ML

    HAND SANITIZER 120 ML

    Hand Sanitizer

    moisturizes+sanitizes+gel

    4.0 fl. oz (120 mL) NDC: 75525-001-12

    HS LABEL 120 ML

    HAND SANITIZER 250 ML

    Hand Sanitizer

    moisturizes+sanitizes+gel

    8.4 fl. oz (250 mL) NDC: 75525-001-25

    HS LABEL 250 ML

    HAND SANITIZER 60 ML-DISPENSER

    Hand Sanitizer

    moisturizes+sanitizes+gel

    2.02 FL OZ (60 ML)

    NDC:75525-001-07

    HS LABEL 60ML DISP

    HAND SANITIZER 2000 ML DISP

    Hand Sanitizer

    moisturizes+sanitizes+gel

    67.6 fl. oz (2000 mL) NDC: 75525-001-21

    HS LABEL 2000 ML DISP

    HAND SANITIZER 3875 ML DISP

    Hand Sanitizer

    moisturizes+sanitizes+gel

    131 fl. oz (3875 mL) NDC: 75525-001-40

    HS LABEL 3875 ML

    HAND SANITIZER 1000 ML DISP

    Hand Sanitizer

    moisturizes+sanitizes+gel

    33.8 fl. oz (1000 mL) NDC: 75525-001-11

    HS LABEL 1000 ML DISP

    HAND SANITIZER 500 ML DISP

    Hand Sanitizer

    moisturizes+sanitizes+gel

    16.9 fl. oz (500 mL) NDC: 75525-001-51

    HS LABEL 500 ML DISP

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER SMELLS CLEAN 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75525-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENESIN (UNII: I670DAL4SZ) (CHLORPHENESIN - UNII:I670DAL4SZ) CHLORPHENESIN0.143 g  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.143 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.2685 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.95 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.8 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.009 g  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.479 g  in 100 mL
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.095 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75525-001-0660 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    2NDC:75525-001-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    3NDC:75525-001-101000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    4NDC:75525-001-202000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    5NDC:75525-001-25250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    6NDC:75525-001-12120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    7NDC:75525-001-0760 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    8NDC:75525-001-51500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/30/2020
    9NDC:75525-001-111000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/30/2020
    10NDC:75525-001-212000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/30/2020
    11NDC:75525-001-403875 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - IWANNA CORP SAS (883223177)
    Registrant - MASTER CUSTOMS BROKER (054631555)
    Establishment
    NameAddressID/FEIBusiness Operations
    IWANNA CORP SAS883223177manufacture(75525-001)
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