Label: ANTIBACTERIAL HAND SANITIZER- alcohol liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):     78887-001-01, 78887-001-02, 78887-001-03, 78887-001-04, view more
    78887-001-05, 78887-001-06, 78887-001-07, 78887-001-08, 78887-001-09, 78887-001-10, 78887-001-11, 78887-001-12, 78887-001-13, 78887-001-14, 78887-001-15, 78887-001-16, 78887-001-17, 78887-001-18, 78887-001-19, 78887-001-20, 78887-001-21, 78887-001-22, 78887-001-23, 78887-001-24, 78887-001-25, 78887-001-26
  • Packager: Ankit LLC
  • 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 June 14, 2020

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  • Active Ingredient

    Alcohol 75% v/v.

  • Purpose

    Antiseptic

  • Uses

    Eliminate bacteria and viral matter on the skin.

  • Warnings

    Do not use

    • on children under 2 months of age
    • on open wounds

    When using:

    Avoid contact with face. eyes. and broken skin. In case of eye contact, flush with clean water and seek medical assistance.

    Stop use and contact a doctor if:
    Irritation or redness occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of ingestion. seek medical help or contact a Poison Control Center immediately.

  • Directions

    • Dispense a liberal amount of product on hands, enough to coat palms and fingers and then rub until dry.
    • Supervise small children to ensure proper usage and prevent ingestion.
  • Other information

    • Store below 110°F[43°C].
    • May discolor certain fabrics/surfaces.
  • Inactive ingredients

    Water, Aloe, Carbomer, Triethanolamine.

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78887-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78887-001-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    2NDC:78887-001-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    3NDC:78887-001-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    4NDC:78887-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    5NDC:78887-001-05237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    6NDC:78887-001-06250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    7NDC:78887-001-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    8NDC:78887-001-08500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    9NDC:78887-001-09887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    10NDC:78887-001-10946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    11NDC:78887-001-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    12NDC:78887-001-122000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    13NDC:78887-001-133000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    14NDC:78887-001-143800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    15NDC:78887-001-154000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    16NDC:78887-001-165000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    17NDC:78887-001-177600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    18NDC:78887-001-1810000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    19NDC:78887-001-1911400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    20NDC:78887-001-2018900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    21NDC:78887-001-2120000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    22NDC:78887-001-2237900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    23NDC:78887-001-2350000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    24NDC:78887-001-24100000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    25NDC:78887-001-25150000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    26NDC:78887-001-26200000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/13/2020
    Labeler - Ankit LLC (805718140)
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