Label: HAND SANITIZER gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    50260-200-01, 50260-200-02, 50260-200-03, 50260-200-04, view more
    50260-200-05, 50260-200-06, 50260-200-07, 50260-200-08, 50260-200-09, 50260-200-10, 50260-200-11, 50260-200-12, 50260-200-13
  • Packager: Fercy Personal Care Products Co Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 1, 2010

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

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to reduce bacteria on the skin that potentially can cause disease

  • Warning

    Flamable, keep away from children or flame.

    For external use only.
                                                 
    Do not use in the eyes.In case of accidental contact with eyes,

    flush eyes with water. Consult a doctor.
                                                   
    Discontinue use if irritation or redness develop.If condition

    persists for more than 72 hours,consult a doctor.
                                                  
    Keep out of reach of children.If swallowed, get medical help

    or contact a Poison Control Center right away.

  • Directions

    Wet hands thoroughly with product and rub hands together until dry. No need to wash or rinse your hands

    or use towels.

    Supervise children under 6 years of age.

  • Other Information

    ·Do not store above 110 oF(43 oC).

    ·May discolor some fabrics, or may ham some wood finishes

    and plastics.


    Deionized water,Glycerin,Propylene Glycol,Triethanolamine,Carbomer,Methylparaben,Propylparaben,Fragrance.


  • PRINCIPAL DISPLAY PANEL

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    phot of druglisting

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50260-200
    Route of AdministrationPERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 31.1 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 1 mL  in 100 mL
    CARBOMER 934 (UNII: Z135WT9208) 0.9 mL  in 100 mL
    Methylparaben (UNII: A2I8C7HI9T) 0.5 mL  in 100 mL
    Propylparaben (UNII: Z8IX2SC1OH) 0.5 mL  in 100 mL
    Product Characteristics
    Colorblue, green, red, pink, yellowScore    
    ShapeSize
    FlavorAPPLE, BANANA, BERRY, GRAPE, CHERRY, MANGO, LEMON, BLUEBERRY, PEACH, STRAWBERRY, ORANGE, WATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50260-200-015 mL in 1 BOTTLE, PLASTIC
    2NDC:50260-200-028 mL in 1 BOTTLE, PLASTIC
    3NDC:50260-200-0310 mL in 1 BOTTLE, PLASTIC
    4NDC:50260-200-0420 mL in 1 BOTTLE, PLASTIC
    5NDC:50260-200-0530 mL in 1 BOTTLE, PLASTIC
    6NDC:50260-200-0650 mL in 1 BOTTLE, PLASTIC
    7NDC:50260-200-0760 mL in 1 BOTTLE, PLASTIC
    8NDC:50260-200-08100 mL in 1 BOTTLE, PLASTIC
    9NDC:50260-200-09120 mL in 1 BOTTLE, PLASTIC
    10NDC:50260-200-10240 mL in 1 BOTTLE, PLASTIC
    11NDC:50260-200-11360 mL in 1 BOTTLE, PLASTIC
    12NDC:50260-200-12500 mL in 1 BOTTLE, PLASTIC
    13NDC:50260-200-131000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34802/01/2010
    Labeler - Fercy Personal Care Products Co Limited (529623870)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fercy Personal Care Products Co Limited529623870manufacture