Label: DELJINE HAND SANITIZER GEL- alcohol gel
DELJINE HAND SANITIZER- alcohol spray

  • 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 August 21, 2020

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  • Active Ingredient(s)

    Ethyl alcohol (Ethanol)-70 % V/V / Alcool Ethylique 70% V/V

  • Purpose

    Antibacterial (skin) cleanser. Antiseptic (skin) cleanser. Effective in destroying (harmful) bacteria to provide antiseptic cleansing.

  • Use

    For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria/germs. Medicated (skin) cleanser. For use when soap and water are not available.

  • Warnings

    Flammability warning. Keep away from open flame and sources of heat. For external use only.

  • Do not use

    • Do not use on children/infants less than 2 years of age (unless directed by a doctor/ physician/ health care practitioner/ health care provider/ health care professional). Do not use on open skin wounds
  • WHEN USING

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

  • STOP USE

    Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation or rash develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

  • Directions

    • Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product. For occasional and personal domestic use.
  • Other information

    • Store between 15-30C (59-86F), Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water/ Aqua/Eau , Ammonium Acryloyldimethyltaurate, Glycerin, Aloe Barbadensis Leaf Juice, d-alpha-tochopheryl Acetate, fragrance (green tea coriander and mandarin)/ parfum (thé vert coriandre et mandarine).

  • Package Label - Principal Display Panel

    NDC: 78064-001-10Hand sanitizer gel 1000 ml, NDC: 78064-001-10

    Hand sanitizer 3.78 L

    78064-001-02

    78064-001-01

    front label of spary

    78064-002-02

    back of label spray

  • INGREDIENTS AND APPEARANCE
    DELJINE HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78064-001
    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)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78064-001-02200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/22/2020
    2NDC:78064-001-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/21/2020
    3NDC:78064-001-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/21/2020
    4NDC:78064-001-403780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/21/2020
    DELJINE HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78064-002
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78064-002-02236.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/22/2020
    Labeler - Deljine Cosmetics corporation (204124143)
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