Label: DISINFEX- alcohol gel

  • 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 July 22, 2020

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  • SPL UNCLASSIFIED SECTION

    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) 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 (0.5% v/v).
    3. Aloe Vera Leaf (0.1% v/v).
    4. Carbomer 940 (0.3% v/v).
    5. Aminomethylpropanol (0.15% v/v).
    6. Sterile distilled water

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Disinfex Hand Sanitizer

  • Uses

    to help reduce bacteria on the skin. For use when soap and water are not avaliable.

  • Warnings

    For external use only. Flammable liquid and vapor. Keep away from heat/sparks/open flame. No smoking. Avoid sprayin in eyes.

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness devolops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison Control Center immediately.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together until dry.
    • Children under 6 years should be supervised when using this product.
  • Other information

    • Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)
    • may discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Carbomer, Aminomethylpropanol.

  • Package Label - Principal Display Panel

    100 mL NDC: 79320-120-02 100 ml label

  • INGREDIENTS AND APPEARANCE
    DISINFEX 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79320-120
    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) 0.5 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.3 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.15 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79320-120-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    Labeler - RK KOZMETIK VE HIJYEN URUNLERI SANAYI DIS TICARET ANONIM SIRKETI (520068126)
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