Label: PETE AND PEDRO SANITIZE- isopropyl alcohol gel

  • NDC Code(s): 52261-0902-1
  • Packager: Cosco International, Inc.
  • 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 May 1, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial

  • Use

    • Hand Sanitizer to decrease bacteria on the skin.
    • Recommended for repeated use
  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame

  • Do not use

    Do not use in or near the eyes.  If contact occurs, rinse throughly with water.

  • STOP USE

    Stop use and ask a doctor if rash or irritation develops and lasts more than 24 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Wet hands thoroughly with product, rub hands together until dry.
    Children under 6 years of age should be supervised when using this product.

  • Other information

    • Store at room temperature (68º-77ºF / 20º-25ºC)
    • Do not expose to heat
    • May discolor certain fabrics
  • Inactive Ingredients

    Aminomethylpropanol, Carbomer, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Water

  • PRINCIPAL DISPLAY PANEL

    4oz label

  • INGREDIENTS AND APPEARANCE
    PETE AND PEDRO SANITIZE 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-0902-10.120 L in 1 TUBE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-0902)
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