Label: APPLE FOAMING HAND SANITIZER 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 January 21, 2022

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  • Active Ingredient(s)

    Alcohol 62% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    purified water USP, glycerin, PEG-10 dimethicone, fragrance

  • Package Label - Principal Display Panel

    1 gallon NDC: 75009-662-01

    3780ml label

    5 gallon NDC: 75009-662-02

    18920ml label

    55 gallon NDC: 75009-662-03

    208190ml label

    275 gallon NDC: 75009-662-04

    1040980ml label

  • INGREDIENTS AND APPEARANCE
    APPLE FOAMING HAND SANITIZER 
    apple foaming hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75009-662
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75009-662-013780 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
    2NDC:75009-662-0218920 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    3NDC:75009-662-03208190 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    4NDC:75009-662-041040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Alpha Aromatics (041723545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alpha Aromatics041723545manufacture(75009-662)
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