Label: 3D ANTISEPTIC HAND SANITIZER- isopropyl alcohol gel

  • 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 September 11, 2020

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  • Drug Facts

  • Active ingredient

    Isopropyl alcohol 70%

  • 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 72hours

    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)
    • may discolor certain fabrics or surfaces
  • Inactive ingredients

    aloe vera extract, glycerin, carbomer, fragrance, reverse osmosis water

  • Questions?

    +1-888-999-7627

    You may also report serious side effects to this number. Mon-Fri 8:30 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    ALL PURPOSE

    ORGANIC

    WITH ALOE VERA HAND SOFTNER

    TSA APPROVED SIZE

    MADE IN USA

    Manufactured by: 3D International, LLC.
    20724 Centre Pointe Parkway,Unit 1
    Santa Clarita, CA 91350

    FRESH SCENTED

    CALIFORNIA PROPOSITION

    PROP 65

    FORMULATED IN ACCORDANCE WITH CDC RECOMMENDATIONS

    Does not contain triclosan, benzalkonium chloride, or phthalates

    FOR EMERGENCY CALLCHEMTREC (800) 424 9300

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    3D ANTISEPTIC HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80286-923
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80286-923-160.47 L in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
    2NDC:80286-923-641.89 L in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
    3NDC:80286-923-013.79 L in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/28/2020
    Labeler - 3d International Llc (044018501)
    Establishment
    NameAddressID/FEIBusiness Operations
    3d International Llc044018501manufacture(80286-923)
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