Label: ORBEL ANTISEPTIC HAND RUB- 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 25, 2020

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  • Drug Facts

  • Active Ingredients

    Ethyl Alcohol 72%

    Purpose

    Antiseptic

  • Use

    Antiseptic hand rub to decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use.

  • Warnings

    Flammable, keep away from fire or flame

    • For external use only
    • Avoid contact with eyes
    • In case of eye contact, rinse eyes thoroughly with water
    • Discontinue use if irritation and redness develop
    • consult a doctor if condition persists for more than 72 hours
    • If swallowed, immediately call Poison Control Center or doctor

    Keep out of reach of children.

  • Directions

    Apply a small amount into your palms and thoroughly spread on both hands. Rub into skin until dry.

  • Other Information

    Store at 68-77F

  • Inactive Ingredients

    DI water, fragrance, glycerin, hydroxyethylcellulose, methylglucamine.

  • Questions or Comments

    Call [813] 541-5300

    Hours M-F 9am-4pm (EST)

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ORBEL ANTISEPTIC HAND RUB 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79723-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.72 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79723-001-0160 mL in 1 POUCH; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2019
    Labeler - Glo-Med Networks Inc. (057540206)