Label: SWEET CANDY KISS SANITIZER PEN- 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 July 23, 2010

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

  • 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

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SWEET CANDY KISS SANITIZER PEN 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34460-6006
    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) 0.002 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.005 g  in 100 g
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.003 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34460-6006-110 g in 1 BOTTLE
    2NDC:34460-6006-290 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