Label: KERN SANI, INC HAND SANITIZER - OCEAN BREEZE GEL- alcohol solution

  • 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, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient[s]

    Alcohol 70%v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use[s]

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

  • WARNINGS

    Warnings

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

  • DO NOT USE

    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

    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 40C (104F)
  • INACTIVE INGREDIENT

    Inactive ingredients aloe vera extract, carbomer 980 powder, fragrance,

    glycerol, hydrogen peroxide, purified water USP, triethanolamine

  • Principal Display Package

    KERN

    SANI

           PREMIUM

    HAND SANITIZER

    OCEAN BREEZE GEL

    ​NON-STERILE SOLUTION

    ​ALCOHOL ANTISEPTIC 70%

      8 FL OZ (236 mL)

    Manufactured and distributed by Kern Sani Inc.

    5016 California Ave. Suite3, Bakersfield, CA 93309

    Lot#

    Exp.

    006-02 8OZ OcnBrz Gel

    006-03 16OZ OcnBrz Gel

    006-04 32OZ OcnBrz Gel

    006-11 1Gal OcnBrz Gel

    006-12 5Gal OcnBrz Gel

    006-13 50Gal OcnBrz Gel

    res

  • INGREDIENTS AND APPEARANCE
    KERN SANI, INC HAND SANITIZER - OCEAN BREEZE GEL 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77804-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77804-006-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
    2NDC:77804-006-03473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
    3NDC:77804-006-04946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
    4NDC:77804-006-113785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
    5NDC:77804-006-1218925 mL in 1 JUG; Type 0: Not a Combination Product04/30/2020
    6NDC:77804-006-13189250 mL in 1 DRUM; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/30/2020
    Labeler - KERN SANI, INC. (117518909)
    Registrant - KERN SANI, INC. (117518909)
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