Label: SCCUSS HAND SANITIZER GEL 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 August 10, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    75% Ethanol

  • Purpose

    Antiseptic

  • Use

    Highly effective alcohol based hand sanitising gel.
    Use anywhere without the need for water.
    For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

  • Do not use

    In children less than 2 months of age.
    On open skin wounds.

  • WHEN USING

    Avoid contact with eyes. In case of eye contact, immediately flush eyes with water.
    Do not use on broken or irritated skin.

  • STOP USE

    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

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

  • Directions

    Apply onto hand and rub over palms, back of hands and fingers until dry.
    Do not wash after use.
    Not recommended for infants.

  • Other information

    Store in a well-ventilated place. Keep cool.

  • Inactive ingredients

    Aqua, Glycerin, Fragrance, Triethanolamine, Carbomer, Aloe Vera, Vitamin E.

  • Package Label - Principal Display Panel

    500 1000 1500 3780 500050 100 236 250 355

  • INGREDIENTS AND APPEARANCE
    SCCUSS HAND SANITIZER GEL 
    sccuss hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80035-001
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    FRAGRANCE GREEN APPLE ORC2001072 (UNII: U9GH30P956)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80035-001-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:80035-001-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:80035-001-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:80035-001-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:80035-001-05355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:80035-001-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:80035-001-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    8NDC:80035-001-081500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    9NDC:80035-001-093780 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    10NDC:80035-001-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Guangzhou AOCAI Bio-Technology Co., Ltd. (554543943)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou AOCAI Bio-Technology Co., Ltd.554543943manufacture(80035-001)