Label: SHIELD DR.- hand sanitizer liquid spray with peppermint and rosemary, 70% 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 August 20, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70%

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical attention or contact poison control center immediately

  • INACTIVE INGREDIENT

    Purified water, Isopropyl myristate, Fragrance, Yellow ( C.I. 47005), Red (C.I. 14720), Blue ( C.I. 42090)

  • DOSAGE & ADMINISTRATION

    Wet hand thoroughly with spray and rub hand together briskly until dry. Children under the age of 6 should be supervised while using this product. Not recommended for infants.

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on the skin it could cause disease

  • WARNINGS

    For external use only.

    Flammable, keep away from fire or source of ignition.

  • STORAGE AND HANDLING

    Store at room temperature 66 oF to 77 oF ( 20 oC to 25 oC)

  • PRINCIPAL DISPLAY PANEL

    59ml NDC:79633-305-59

    Shield Dr. hand sanitizer liquid spray label 6

  • INGREDIENTS AND APPEARANCE
    SHIELD DR. 
    hand sanitizer liquid spray with peppermint and rosemary, 70% alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79633-305
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    CARMOISINE (UNII: DR4641L47F)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79633-305-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/20/2020
    Labeler - MEDIPHARCO PHARMACEUTICAL JOINT STOCK COMPANY (555273697)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDIPHARCO PHARMACEUTICAL JOINT STOCK COMPANY555273697manufacture(79633-305)
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