Label: AMMONIA INHALANT- ammonia aerosol
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Contains inactivated NDC Code(s)
NDC Code(s): 73395-196-01 - Packager: AmmoniaSport LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 27, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMMONIA INHALANT
ammonia aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73395-196 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g in 0.3 mL Inactive Ingredients Ingredient Name Strength NUTMEG OIL (UNII: Z1CLM48948) FD&C RED NO. 40 (UNII: WZB9127XOA) LAVENDER OIL (UNII: ZBP1YXW0H8) ALCOHOL (UNII: 3K9958V90M) LEMON OIL (UNII: I9GRO824LL) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73395-196-01 25 in 1 BOTTLE, PLASTIC 08/19/2017 1 0.3 mL in 1 CAPSULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/19/2017 Labeler - AmmoniaSport LLC (048476710) Establishment Name Address ID/FEI Business Operations James Alexander Corp. 040756421 manufacture(73395-196)