Label: ADVANCED GEL HAND SANITIZER SOOTHING LAVENDER- 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 21, 2021

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  • Active Ingredient(s)

    Ethanol Alcohol 62% w/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Advanced Hand Sanitizer Soothing Lavender

  • 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 children 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

    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

    60mL NDC : 81209-200-03 60mL

    5000 mL NDC: 81209-200-01

    1000mL NDC: 81209-200-02

    5000mL1000mL

  • INGREDIENTS AND APPEARANCE
    ADVANCED GEL HAND SANITIZER SOOTHING LAVENDER 
    ethanol alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81209-200
    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
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    FRAGRANCE LAVENDER ORC1800979 (UNII: 1B40MIN2W5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81209-200-015000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2020
    2NDC:81209-200-021000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
    3NDC:81209-200-0360 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(81209-200)
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