Label: ANTACGEL- hand sanitizer spray with peppermint and lavender, 77% 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 July 21, 2020

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  • ACTIVE INGREDIENT

    Alcohol 77%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Hand sanitizer spray helps to sanitize hands, eliminate unpleasant odor and leave hands feeling soft and fresh.

  • WARNINGS

    For external use only. Flammable. Keep away from the heat or flame.

  • DO NOT USE

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

  • WHEN USING

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • STORAGE AND HANDLING

    * Spray the solution to one hand. Thoroughly rub your hands together until dry.
    * Supervise children under 6 years of age when using this product to avoid swallowing.

    * Store below 86ºF (30ºC)
    * May discolor certain fabrics or surfaces

  • INACTIVE INGREDIENT

    Blue (C.I.42090), Isopropyl myristate, Lavender oil, Peppermint oil, Purified Water, Red (C.I. 45430)

  • DOSAGE & ADMINISTRATION

    * Spray the solution to one hand. Thoroughly rub your hands together until dry.
    * Supervise children under 6 years of age when using this product to avoid swallowing.

  • PRINCIPAL DISPLAY PANEL

    ANTACGEL_Hand Sanitizer Spray with Peppermint and Lavender

  • INGREDIENTS AND APPEARANCE
    ANTACGEL 
    hand sanitizer spray with peppermint and lavender, 77% alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79633-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    ERYTHROSINE SODIUM ANHYDROUS (UNII: 8TL7LH93FM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79633-102-0660 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/21/2020
    Labeler - MEDIPHARCO PHARMACEUTICAL JOINT STOCK COMPANY (555273697)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDIPHARCO PHARMACEUTICAL JOINT STOCK COMPANY555273697manufacture(79633-102)