OROSTAT 8% (EPINEPHRINE HYDROCHLORIDE) SOLUTION [GINGI-PAK A DIVISION OF THE BELPORT]

  • Home
  • OROSTAT 8% (EPINEPHRINE HYDROCHLORIDE) SOLUTION [GINGI-PAK A DIVISION OF THE BELPORT]

OROSTAT 8% (EPINEPHRINE HYDROCHLORIDE) SOLUTION [GINGI-PAK A DIVISION OF THE BELPORT]
PDF | XML
NDC 10129-006-02
Set ID 755005b8-165b-b667-e053-2991aa0a3651
Category HUMAN OTC DRUG LABEL
Packager Gingi-Pak a Division of the Belport
Generic Name
Product Class alpha-Adrenergic Agonist, beta-Adrenergic Agonist
Product Number
Application Number
View All Sections
  • Active Ingredient

    Active Ingredient

  • Purpose

    Purpose

  • Description

    Description

  • Inactive Ingredient

    Inactive ingredients

  • Keep out of reach if children

    Keep out of reach if children

  • Storage

    Storage

  • Uses

    Uses

  • Do not use

    Do not use

  • Warnings

    Warnings

  • Directions

    Directions

  • Principal Display-Orostat 8%

    Principal Display-Orostat 8%

  • INGREDIENTS AND APPEARANCE
    OROSTAT 8% 
    epinephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-006
    Route of AdministrationSUBGINGIVAL, PERIODONTAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE HYDROCHLORIDE1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM DITHIONITE (UNII: 2K5B8F6ES1) 37.5 mg  in 15 mL
    SODIUM THIOSULFATE (UNII: HX1032V43M) 15 mg  in 15 mL
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) 37.5 mg  in 15 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 49.5 mg  in 15 mL
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 4.95 mg  in 15 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.15 mL  in 15 mL
    EDETIC ACID (UNII: 9G34HU7RV0) 1.995 mg  in 15 mL
    METHYLPARABEN (UNII: A2I8C7HI9T) 10.05 mg  in 15 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10129-006-0215 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/04/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/04/1990
    Labeler - Gingi-Pak a Division of the Belport (008480121)
    Registrant - Jeff Nichols (008480121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gingi-Pak a Division of the Belport008480121manufacture(10129-006)
View All Sections

Related Drugs

Search DailyMed Drugs