Label: CODE BROWN- isopropyl alcohol liquid

  • 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 17, 2016

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  • Drug Facts

  • Active Ingredient

    70% Isopropyl Alcohol v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease, recommended for repeated use.

  • WARNINGS

    Warnings   FLAMMABLE

    Keep away from fire or flame.

    For external use only. 

    When using this product 

    • Do not use in or near 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

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

  • DOSAGE & ADMINISTRATION

    Directions • Apply product to hands and rub into skin until dry. Children under 6 yrs old should be supervised by an adult when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Essential Oil Blend, Vitis Vinifera (Grape) Seed Oil, Water (Aqua)

  • STORAGE AND HANDLING

    Other information 

    • Do not store above 104°F/40°C

    • May discolor some fabrics.

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF GERMS

    original scent powered by natural essential oils.

    Promotes proper hand hygiene and prevents the spread of hospital acquired infections

    BACKED WITH GRAPESEED OIL to prevent dry cracked hands.

    Distributed by: LaDiDah Essentials, LLC

    PO BOX 2441 Gilbert, AZ 85288

    LaDiDahEssentials.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    CODE BROWN 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70913-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70913-001-1010 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2016
    2NDC:70913-001-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2016
    3NDC:70913-001-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2016
    4NDC:70913-001-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2016
    5NDC:70913-001-123785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/25/2016
    Labeler - Ladidah Essentials, Llc (080146986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ladidah Essentials, Llc080146986manufacture(70913-001)
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