FROSTED BERRIES AND CREAM SANITIZER PEN (ALCOHOL) LIQUID [ZHEJIANG BLUE DREAM COSMETICS CO., LTD.]

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  • FROSTED BERRIES AND CREAM SANITIZER PEN (ALCOHOL) LIQUID [ZHEJIANG BLUE DREAM COSMETICS CO., LTD.]

FROSTED BERRIES AND CREAM SANITIZER PEN (ALCOHOL) LIQUID [ZHEJIANG BLUE DREAM COSMETICS CO., LTD.]
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NDC 34460-6005-1, 34460-6005-2
Set ID 4a128c3b-9775-42d0-b6c3-21d7d2bd3f77
Category HUMAN OTC DRUG LABEL
Packager Zhejiang Blue Dream Cosmetics Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART333
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  • ACTIVE INGREDIENT

    Active Ingredient      Ethyl Alcohol     62%

    Purpose                      Antiseptic 

  • DESCRIPTION

    Uses: 

    To decrease bacteria on skin that could cause disease

    Recommended for repeated use

  • WARNINGS

    Warnings:

    For external use only

    Flammable. Keep away from heat and flame.

    When using this product

    • Keep out of eyes.  In case of contact with eyes, flush thoroughly with water
    • Avoid contact with broken skin
    • Do not inhale or ingest

    Stop use and ask a doctor if skin irritation develops

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

  • DOSAGE & ADMINISTRATION

    Directions:

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


  • STORAGE AND HANDLING

    Other Information

    • Do not store above 105F
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
  • INACTIVE INGREDIENT


    Inactive Ingredients:

    Water, Glycerin, Triethanolamine, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil, FDA and C Blue No. 1, FD and C Red No. 40, FD and C Yellow No. 5
  • PRINCIPAL DISPLAY PANEL

    labellabel

  • PRINCIPAL DISPLAY PANEL

    backback label

  • INGREDIENTS AND APPEARANCE
    FROSTED BERRIES AND CREAM SANITIZER PEN 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34460-6005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 35.16 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2.0 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.2 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.2 g  in 100 g
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.1 g  in 100 g
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.2 g  in 100 g
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.003 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.002 g  in 100 g
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.005 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34460-6005-110 g in 1 BOTTLE
    2NDC:34460-6005-290 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33308/07/2010
    Labeler - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)
    Registrant - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Blue Dream Cosmetics Co., Ltd.529047234manufacture
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