Label: QUALITY CHOICE AROMATIC AMMONIA SPIRIT- ammonia 2% liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 19, 2020

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  • WARNINGS AND PRECAUTIONS

     Drug Facts

  • Active Ingredient

     Ammonia 2 %

  • Purpose

     Respiratory Stimulant

  • Indication

    Respiratory stimulant used as a smelling salts to treat or prevent fainting.

  • Warnings

     For external use only. Avoid eye contact with liquid vapors. Avoid inhaling more than a slight whiff. May cause irritation if excess is inhaled.

  • If pregnant or nursing a baby

     seek the advice of a doctor before using this product.

  • Keep out of the reach of children

     In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

  • Directions

     Inhale a slight whiff to treat a "faining spell"

  • Inactive Ingredients

     Ammonium Carbonate, Ethyl Alcohol 656%, Lavender Oil, Lemon Oil Terpenless, Myristica Oil and Purified Water.

  • Other Information

     Flammable: Keep away from spark, heat or flame. Keep tightly closed at room temperature not toexceed 30C (86F).

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE AROMATIC AMMONIA SPIRIT 
    ammonia 2% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-489
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ)  
    ALCOHOL (UNII: 3K9958V90M)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LEMON OIL, TERPENELESS (UNII: X69W83NI7V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-489-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2008
    Labeler - Chain Drug Market Association (011920774)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(63868-489) , analysis(63868-489) , pack(63868-489) , label(63868-489)
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