Label: THE SAEM CLEAN EVERYDAY HAND SANITIZER GEL- 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 13, 2020

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  • Active ingredient

    Ethyl alcohol 70%

  • Purpose

    Antimicrobial

  • Use

    • Hand sanitizer to help reduce bacteria on the skin
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts

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

  • Directions

    • Put nough produt in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water, Dipropylene Glycol, Carbomer, Glycerin, Triethanolamine, PEG-60 Hydrogenated Caster Oil, Panthenol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Diethanolamine, Citrus Paradisi (Grapefruit) Peel Oil, Sodium Hyaluronate

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    THE SAEM CLEAN EVERYDAY HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIETHANOLAMINE (UNII: AZE05TDV2V)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70341-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
    2NDC:70341-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
    3NDC:70341-001-03100 mL in 1 TUBE; Type 0: Not a Combination Product04/13/2020
    4NDC:70341-001-04250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/13/2020
    5NDC:70341-001-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
    6NDC:70341-001-06500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/13/2020
    Labeler - The Saem International Co., Ltd. (689402402)
    Registrant - The Saem International Co., Ltd. (689402402)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rainbow Co Ltd690423720manufacture(70341-001)
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