Label: WATERLESS ANTI-BACTERIAL HAND CLEANSER - alcohol liquid 

  • Label RSS
  • NDC Code(s): 49852-180-45, 49852-180-60, 49852-180-80
  • Packager: Tri-Coastal Design Company Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/14

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

  • Active Ingredient

    Ethyl Alcohol 62%

    Close
  • Purpose

    Antiseptic

    Close
  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
    Close
  • Warnings

    • For external use only
    • Flammable, keep away from fire and flame
    • Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances
    Close
  • When using this product

    • Avoid the eyes and mucous membranes
    • In the case of eyes or mucous membrane contact; rinse area thoroughly with water Use only as directed
    Close
  • Stop use and ask a doctor if

    • Condition worsens
    • Redness or irritation develops
    • If condition persists for more than 3 days
    Close
  • Keep out of reach of children

    If swallowed contact a doctor or Poison Control Center immediately.

    Close
  • Directions

    • Rub dime sized amount between hands until dry
    • Supervise children in the use of this product
    • in the case of eye contact, rinse eyes thoroughly with water
    Close
  • Other information

    • Store below 105F
    • May discolor some fabrics
    Close
  • Inactive Ingredients

    Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum), DC Red 33, FDC Blue 1

    Close
  • Package Label
  • INGREDIENTS AND APPEARANCE
    WATERLESS ANTI-BACTERIAL HAND CLEANSER 
    alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49852-180
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 62 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    PROPYLENE GLYCOL  
    TROLAMINE  
    ALOE VERA LEAF  
    ALPHA-TOCOPHEROL ACETATE  
    D&C RED NO. 33  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49852-180-45 45 mL in 1 BOTTLE, PLASTIC
    2 NDC:49852-180-60 60 mL in 1 TUBE
    3 NDC:49852-180-80 237 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 07/15/2013
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Pulisi Daily Chemical Products Co.,Ltd. 529047265 manufacture(49852-180)
    Close