Label: MELLOW INSTANT HAND SANITIZER 8 OZ- ethyl 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 April 8, 2020

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  • Drug Facts

  • Medicinal Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Non Medicinal

    Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Parfum, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, FD&C Yellow No. 5(Tartrazine), FD&C Blue No. 1

  • Features

    ♦ To decrease bacteria on the skin that could cause disease.

    ♦ Recommended for repeated use.

    ♦ Use anywhere without water.

  • Directions

    ♦ Wet hands thoroughly with product and rub until dry without wiping.

    ♦ For children under 6, use only under adult supervision.

    ♦ Not recommended for infants.

  • Warning

    ♦ For external use only-hands. 

    ♦ Flammable. Keep away from heat and flame.

    ♦ Discontinue if skin becomes irritated and ask a doctor.

    When using this product

    ♦ Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    ♦ Do not inhale or ingest.

    ♦ Avoid contact with broken skin.

    ♦ Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Other information

    ♦ Do not store above 105°F 

    ♦ May discolor some fabrics, 

    ♦ Harmful to wood finishes and plastics.

  • SPL UNCLASSIFIED SECTION

    With Aloe and Vitamin E

    Kills 99.99% of Germs

    This product was not tested on animals.

    Used under Lic. & Dist.By:

    LANTERN BEAUTY AMERICA INC

    Address: 1401 E, Cedar Street, Unit C, Ontario, CA 91761, USA

    TEL: 909-799-9700

    Web:LanternBeauty.com

    Made in China

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MELLOW INSTANT HAND SANITIZER 8 OZ 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-033
    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
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-033-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/06/2020
    Labeler - Ashtel Studios, Inc (148689180)
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