Label: BERRY HAND SANITIZER WITH VITAMIN E AND ALOE- 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 June 26, 2014

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  • Active Ingredient

    Ethyl Alcohol 62%

    Purpose

    Sanitizer

  • Uses

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

    For external use only- hands.

    Use only as directed

    Excessive use or prolonged exposure may cause irritation to skin.

    Discontinue use if rash, redness or itching occurs.

    Flammable. Keep away from heat and flame.

    When using this product

    • keep out of eyes. In case of contact with eyes, immediately flush with water and call a doctor.
    • avoid contact with broken skin.

    Stop use and ask a doctor if

    irritation or redness develops

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    put a thumb size amount in your palm and rub hands together briskly until dry.

  • Other Information

    • do not store in temperatures over 118F
    • Children under 6 years of age should be supervised while using this product
    • may discolor certain fabrics
  • Inactive Ingredients

    aloe barbadensis gel, carbomer, fragrance, glycerin, propylene glycol, tocopherol, triethanolamine, water.

  • Product Labeling

    Hand Sanitizer

    net 1.5 fl oz (44.3mL)

    Manufactured for

    MGS Group, Ltd.

    Made in China

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    BERRY HAND SANITIZER WITH VITAMIN E AND ALOE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51263-3184
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51263-3184-244.3 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/26/2014
    Labeler - MGS Group Limited (663512177)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(51263-3184)
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