HAND SANITIZER (ETHYL ALCOHOL) GEL [RAINING ROSE, INC.]

HAND SANITIZER (ETHYL ALCOHOL) GEL [RAINING ROSE, INC.]
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NDC 65692-1002-1
Set ID 416267f2-85c5-6633-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Raining Rose, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Active Ingredient
    Ethanol 65%

  • PURPOSE

    Purpose
    Antiseptic

  • WARNINGS

    Warnings

    Flammable, keep away from fire or flame.

    For external use only.

    Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention.

  • STOP USE

    Stop use and ask doctor if irritation and redness develops and persists for more than 72 hours.

  • 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

    • Dispense an adequate amount in your palm to cover all surfaces of hands completely.
    • Rub hands together until dry.
    • Does not require rinsing.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Triethanolamine.

  • INDICATIONS & USAGE

    Uses

    • For handwashing to decrease bacteria on the skin.
    • Recommended for repeated use.
  • Other Information

    • Do not store above 105 F
    • May discolor some fabrics.
  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-1002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-1002-129 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/16/2016
    Labeler - Raining Rose, Inc. (083819404)

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