Label: HAND SANITIZER- alcohol gel 

  • NDC Code(s): 11822-0440-2, 11822-0440-8
  • Packager: Rite Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • Active ingredients

    Active ingredients

    Ethyl Alcohol 65%

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  • Purpose

    Purpose

    Antiseptic

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  • Use

    Use

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
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  • Warnings

    Warnings

    For external use only-hands

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  • Flammable

    Flammable. Keep away from heat and flame

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  • when using

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water
    • avoid contact wit broken skin
    • do not inhale or ingest
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  • Stop use

    Stop use ad ask a doctor if skin irritation develops

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  • 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.

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  • Directions

    Directions

    • Wet hands thoroughly with product and allow to dr without wiping
    • For children under 6, use only under adult supervision
    • Not recommended for infants
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  • Other information

    Other information:

    • Do not store above 105°F
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
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  • Inactive ingredients

    Inactive ingredients benzopheone-4, butyrospermum parkii (shea butter), carbomer, cellulose, fragrance, glycerin, hydroxypropyl methylcellulose, iron oxides, isopropyl myristate, mannitol, propylene glycol, tocopheryl acetate, water

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  • Claims

    Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds

    Made in USA with US and foreign components

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  • Adverse Reactions

    Distributedm by Rite Aid

    30 Hunter Lane, Camp Hill, PA17011

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  • Principal display panel

    RITE

    AID

    RENEWAL

    Instant

    HAND SANITIZER

    with

    SHEA BUTTER

    Kills 99.99% of Germs

    Leaves Hands Feeling

    Soft And Refreshed

    8 FL OZ

    (236 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0440
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 585 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SULISOBENZONE  
    SHEA BUTTER  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
    POWDERED CELLULOSE  
    GLYCERIN  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    ISOPROPYL MYRISTATE  
    MANNITOL  
    PROPYLENE GLYCOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0440-8 236 mL in 1 BOTTLE, PUMP
    2 NDC:11822-0440-2 59 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 07/12/2010
    Labeler - Rite Aid (014578892)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 088520668 manufacture(11822-0440)
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