Label: HAND SANITIZER GREEN- alcohol gel
HAND SANITIZER- alcohol gel
HAND SANITIZER BLUE- alcohol 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 October 2, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help to decrease bacteria on the skin that could cause disease. Recommended for repeted use.

  • Warnings

    For external use only: hands. Flammable. Keep away from fire or flame.

  • WHEN USING

    Keep out of eyes, in case of contact, flush thoroughly with water. Avoid contact with broken skin. Do not inhale nor ingest.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children if swallowed, get medical help or contact a Poisson Control Center immediately.

  • Directions

    • Put enough product in hands to cover them, rub them together briskly until dry.
    • Children under 6 years old need adult supervision to use this product.
  • Other information

    • Store in a cool, dry place at a temperature from 32°F to 95°F.
  • Inactive ingredients

    carbomer, demineralized water, glycerin, Microcare®CB (benzyl alcohol and a mixture of methylchloroisothiazolinone and methylisothiazolinone) and triethanolamine. May contain FD&C Blue No. 1, FD&C Blue No. 2, FD&C Yellow No. 5 (tartrazine) and/or FD&C Yellow No. 6.

  • QUESTIONS

    Questions? +52 444 823 5650

  • Label NDC 79008-001

    1000 mL NDC: 79008-001-01

    Hand Sanitizer Label Sample

  • Label NDC: 79008-001-02

    220 mL NDC: 79008-001-02

    Hand Sanitizer Label 220 ml

  • Label NDC 79008-001-03

    1000 mL NDC: 79008-001-03

    Bottle w/dispenser

    Hand Sanitizer Label 1 L w/dispenser

  • Label NDC 79008-002-01

    1000 mL NDC: 79008-002-01

    Hand Sanitizer Label

  • Label NDC: 79008-002-02

    220 mL NDC: 79008-002-02

    Hand Sanitizer Label 220 ml

  • Label NDC 79008-002-03

    1000 mL NDC: 79008-002-03

    Bottle w/dispenser

    Hand Sanitizer Label 1 L w/dispenser

  • Label NDC 79008-003-01

    1000 mL NDC: 79008-003-01

    Hand Sanitizer Label

  • Label NDC: 79008-003-02

    220 mL NDC: 79008-003-02

    Hand Sanitizer Label 220 ml

  • Label NDC 79008-003-03

    1000 mL NDC: 79008-003-03

    Bottle w/dispenser

    Hand Sanitizer Label 1 L w/dispenser

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  GREEN
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79008-002
    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
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79008-002-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/2020
    2NDC:79008-002-02220 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/2020
    3NDC:79008-002-031000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/27/2020
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79008-001
    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)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79008-001-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:79008-001-02220 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:79008-001-031000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    HAND SANITIZER  BLUE
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79008-003
    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
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79008-003-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/2020
    2NDC:79008-003-02220 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/2020
    3NDC:79008-003-031000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/27/2020
    Labeler - Grupo Delveg, S.A. de C.V. (816144521)
    Registrant - Grupo Delveg, S.A. de C.V. (816144521)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grupo Delveg, S.A. de C.V.816144521manufacture(79008-001, 79008-002, 79008-003) , pack(79008-001, 79008-002, 79008-003) , label(79008-001, 79008-002, 79008-003)
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