Label: ANTACGEL- hand sanitizer gel with peppermint and orange, 73% 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 July 22, 2020

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  • ACTIVE INGREDIENT

    Alcohol 73%

  • PURPOSE

    Anticeptic

  • INDICATIONS & USAGE

    Hand sanitizer gel 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

    * Apply a proper amount of gel to one hand. Thoroughly rub your hand 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

    Carbomer, Isopropyl myristate, Orange oil, Peppermint oil, Purified Water, Triethanolamine, Yellow (C.I. 15985)

  • DOSAGE & ADMINISTRATION

    Apply a proper amount of gel to one hand.

  • PRINCIPAL DISPLAY PANEL

    Hand Sanitizer Gel with Peppermint and OrangeHand Sanitizer Gel with Peppermint and Orange

  • INGREDIENTS AND APPEARANCE
    ANTACGEL 
    hand sanitizer gel with peppermint and orange, 73% alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79633-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79633-201-25217 g in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    2NDC:79633-201-45434 g in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/22/2020
    Labeler - MEDIPHARCO PHARMACEUTICAL JOINT STOCK COMPANY (555273697)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDIPHARCO PHARMACEUTICAL JOINT STOCK COMPANY555273697manufacture(79633-201)
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