Label: ORBIT HAND SANITIZER- isopropyl alcohol spray

  • 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 August 27, 2020

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  • Drug Facts

  • Active Ingredient

    Isopropyl Alcohol (70%)

  • Purpose

    Antiseptic

  • Inactive Ingredients

    Glycerine, DM Sterile water, Carbomer, Vitamin E, Aloe Extract, H2O2, Triethanolamine

  • Uses

    ▪ For hand-washing to decrease bacteria on the skin.

    ▪ Recommended for repeated use.

    ▪ Avoid contact with broken skin.

    ▪ Do not inhale or ingest.

  • Other information

    Do not store above 105°F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Questions?

    +1(877)793-8998

  • Warnings

    FOR EXTERNAL USE ONLY - HANDS

    Flammable. Keep away from heat and flame.

    When using this product • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    Stop use and ask a doctor if skin irritates develops.

    Keeps 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.

    For children under 6 years, use only under adult supervision.

    Not a recommendation for infants

  • SPL UNCLASSIFIED SECTION

    Instant HAND SANITIZER with MOISTURIZERS & VITAMIN E

    KILLS ILLNESS CAUSING GERMS UPTO 99.9%

    Manufactured and Distributed

    by: Orbit Capital, LLC.Stafford, Texas.

    www.orbitcapitalllc.com

    Made in USA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ORBIT HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78752-698
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE (UNII: V5VD430YW9)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78752-698-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/25/2020
    2NDC:78752-698-1224 in 1 BOX08/25/2020
    2NDC:78752-698-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:78752-698-226 in 1 CASE08/25/2020
    3NDC:78752-698-1224 in 1 BOX
    3NDC:78752-698-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2020
    Labeler - ORBIT CAPITAL LLC (019289026)
    Establishment
    NameAddressID/FEIBusiness Operations
    ORBIT CAPITAL LLC019289026manufacture(78752-698)
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