Label: CRYSTAL RIDGE HAND SANITIZER- 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 March 28, 2020

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  • ACTIVE INGREDIENT

    Alcohol 80 % v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    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
  • 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.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other Information:

    Store between 15-30c (59-86F)

    Avoid freezing and excessive heat above 40 C (104F)

  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, hydrogen peroxide, purified water USP

  • Hand Sanitizer

    1. 750 mL size bottle NDC 74207-010-07
      750 ml bottle
    2. Back Label
      Back Label with handwritten batch number added
  • Hand Sanitizer

    Back label with handwritten batch number3.78 L jug

    3.78 L plastic jug, NDC 7207-010-40

  • Hand Sanitizer

    18.9L Bucket18.9L bucket label with handwritten batch number included on bucket:

  • INGREDIENTS AND APPEARANCE
    CRYSTAL RIDGE HAND SANITIZER 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74207-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 155 L  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74207-010-07750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/2020
    2NDC:74207-010-403800 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/2020
    3NDC:74207-010-8020000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/28/2020
    Labeler - Crystal Ridge Distillery (029126883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crystal Ridge Distillery029126883manufacture(74207-010)
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