Label: ADVANCED GEL HAND SANITIZER REFRESHING CITRUS- ethanol 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 August 3, 2021

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  • Active Ingredient(s)

    Ethanol Alcohol 62% . Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    For Sanitizing hands to reduce bacteria and virus on the skin

  • Warnings

    Flammable. Keep away from fire or flame

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of childrens or pets.

  • WHEN USING

    Do not put in eyes

  • Directions

    Apply Small amount in your palm and briskly rub hands together until dry.

  • Inactive ingredients

    Water, Glycerin, Carbomer, Fragrance, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Vitamin E, Iron Oxide(CI 77499),Iron Oxide(CI 77492), D&C Red No.30.

  • Package Label - Principal Display Panel

    30ml30ml promotion60ml1000mL5000ml5000 mL NDC: 81209-100-01

    1000mL NDC: 81209-100-02

    30mL NDC :81209-100-03

    30mL promotional NDC :81209-100-04

    60mL NDC :81209-100-05

    60mL Promotional NDC 81209-100-06 60mL Promotional

  • INGREDIENTS AND APPEARANCE
    ADVANCED GEL HAND SANITIZER REFRESHING CITRUS 
    ethanol alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81209-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81209-100-015000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2020
    2NDC:81209-100-021000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    3NDC:81209-100-0330 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/01/2021
    4NDC:81209-100-0430 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/01/2021
    5NDC:81209-100-0560 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/01/2021
    6NDC:81209-100-0660 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2020
    Labeler - BLUETRACK, Inc. (135029937)
    Registrant - NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.LTD (544493972)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO OCEANSTAR CHEMICAL PRODUCTS CO LTD544493972manufacture(81209-100)
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