Label: HAND CARE SET WINTER CITRUS- alcohol kit

  • 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 June 26, 2019

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  • Drug Facts

  • Active ingredient

    Alcohol Denat. 66%

    Purpose

    Antiseptic

  • Use

    • For handwashing to decrease bacteria on the skin
  • Warnings

    For external use only

    • Flammable. Keep away from fire & flame
    • Does not contain grain alcohol; do not drink. If taken internally will produce severe gastric disturbances

    When using this product

    • Avoid the eyes and mucous membranes 
    • In the case of eyes or mucous membrane contact, rinse area thoroughly with water

    Stop use and ask a doctor if 

    • Condition worsens
    • Redness or irritation develops
    • Condition persist for more than 3 days

    Keep out of reach of children. 

    If swallowed, contact a doctor or Poison Control Center immediately.

  • 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
  • Other information

    • Store below 105°F
    • May discolor fabrics
  • Inactive ingredients:

    Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance. May Contain: FD&C Red No.4, FD&C Yellow No.5, FD&C Blue No.1, D&C Red No.33.

  • Questions?

    Call 1-888-988-2427

  • Hand Care Set Winter Citrus (62651-022-00)

    Label2

  • Hand Sanitizer Winter Citrus, 1 oz (62651-008-01)

    Label5

  • INGREDIENTS AND APPEARANCE
    HAND CARE SET WINTER CITRUS 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62651-022
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62651-022-001 in 1 KIT10/15/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 29.5 mL
    Part 1 of 1
    HAND SANITIZER WINTER CITRUS 
    alcohol gel
    Product Information
    Item Code (Source)NDC:62651-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL660 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62651-008-0129.5 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/15/2019
    Labeler - Base4 Ventures, LLC (137316126)
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