RUE21 COCO BREEZE ANTI-BACTERIAL HAND SANITIZER (ALCOHOL) LIQUID [ALILY (ZHANGZHOU) BATH PRODUCTS LTD.]

RUE21 COCO BREEZE ANTI-BACTERIAL HAND SANITIZER (ALCOHOL) LIQUID [ALILY (ZHANGZHOU) BATH PRODUCTS LTD.]
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NDC 49371-041-01
Set ID 655f5bf3-e62b-48fe-88a3-c4ca266b1ca9
Category HUMAN OTC DRUG LABEL
Packager ALILY (ZHANGZHOU) BATH PRODUCTS LTD.
Generic Name
Product Class
Product Number
Application Number PART333
  • ACTIVE INGREDIENT

    Active Ingredient                        Purpose

    Ethyl Alcohol 62%                      Antiseptic

  • INDICATIONS & USAGE

                Uses:

    • To decrease bacteria on the skin that could cause diseases
    • Recommended for repeated use.
  • WARNINGS

    Warnings:

    For external use only-hands.

    Flammable-keep away from heat and flame

    When using this products

    • 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 105 F
    • May discolor some fabrics
    • Harmful to wood finishes and plastics

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (aqua), Glycerin, Triethanolamine, Fragrance (Parfume), PEG-40 Hydrogenated Castor Oil, Carbomer, DMDM Hydantoin, Hydrogenated Jojoba Oil, FD and C Yellow No. 5, FD and C Blue No. 1

  • PRINCIPAL DISPLAY PANEL

    pictLabel picture

  • INGREDIENTS AND APPEARANCE
    RUE21 COCO BREEZE ANTI-BACTERIAL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49371-041
    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) 33.9429 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.3 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.3 g  in 100 g
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.8 g  in 100 g
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.2 g  in 100 g
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.012 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49371-041-0145 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33305/20/2010
    Labeler - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)
    Registrant - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALILY (ZHANGZHOU) BATH PRODUCTS LTD.531064269manufacture

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