Label: PERSONAL CARE HAND SANITIZER ALOE- 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 October 9, 2009

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  • ACTIVE INGREDIENT

    Active Ingredient                              Purpose

    Ethyl Alcohol 62 percent                  Antimicrobial

  • PURPOSE

    Uses

    hand sanitizer to help reduce bacteria on the skin.

  • WARNINGS

    Warnings

    For external use only.

  • SAFE HANDLING WARNING

    Flammable

    Keep away from heat and flame.

  • WHEN USING

    When using this product avoid contact with face, eyes,

    and broken skin. In case of eye contact, flush with plenty

    of water and seek medical advice.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    wet hands thoroughly with product and rub into skin until dry.

    Children under 6 years of age should be supervised by an adult when using this product.

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe barbadensis leaf juice,

    carbomer, fragrance, glycerin, propylene glycol , tocopheryl acetate vitamin E,

    triethanolamine, water aqua, FD and C blue 1, FD and C Yellow 5

  • DESCRIPTION

    Kills 99.9 percent of many common germs.

    Distributed by Personal Care Products, Inc.

    Bingham Farms, MI 48025 3463

    Made in China

  • GUARANTEED ANALYSIS OF FEED

    Personal Care

    Kills 99.9 percent Of Germs

    Hand Sanitizer

    Antibacterial

    with Moisturizers

    and Aloe

    12 Fl oz 355 ml

  • PRINCIPAL DISPLAY PANEL


    HandSanitizerWithAloe

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE HAND SANITIZER ALOE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9280
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9280-1355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/01/2009
    Labeler - Personal Care Products, Inc. (603124298)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co., Ltd528196956manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Life-Beauty Cosmetics Co., Ltd529125509manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture
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