OROSTAT 8%- epinephrine hydrochloride solution
Gingi-Pak a Division of the Belport

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.

----------

Orostat Solution

Active Ingredient

Purpose

Inactive ingredients

OROSTAT 8%
epinephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-006
Route of Administration	SUBGINGIVAL, PERIODONTAL, DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE HYDROCHLORIDE	1200 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10129-006-02	15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/04/1990

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/04/1990

Labeler - Gingi-Pak a Division of the Belport (008480121)

Registrant - Jeff Nichols (008480121)

Name	Address	ID/FEI	Business Operations
Establishment
Gingi-Pak a Division of the Belport		008480121	manufacture(10129-006)