Label: CAL-SHINE ANTISEPTIC HAND SANITIZER- isopropyl alcohol 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 12, 2023

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  • Drug Facts

  • Active ingredient

    Isopropyl alcohol 75% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available
  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use

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

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

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

    aloe vera leaf extract, glycerin, hydrogen peroxide, lavender oil, water

  • Questions? +1-559-412-7402

    You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 4:00 PM

  • SPL UNCLASSIFIED SECTION

    With Lavender Essential Oils and Aloe vera

    Manufactured by:
    California Shine Construction & Sanitizing,
    3251 N Marks Ave, Fresno, CA 93722

    ​MADE IN THE U.S.A.

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    CAL-SHINE ANTISEPTIC HAND SANITIZER 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78604-646
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78604-646-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    2NDC:78604-646-11118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    3NDC:78604-646-23237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    4NDC:78604-646-47474 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    5NDC:78604-646-373785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/10/2020
    Labeler - California Shine Construction (030762135)
    Establishment
    NameAddressID/FEIBusiness Operations
    California Shine Construction030762135manufacture(78604-646)
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