OROSTAT 8%- epinephrine hydrochloride solution

Orostat 8% by

Drug Labeling and Warnings

Orostat 8% by is a Otc medication manufactured, distributed, or labeled by Gingi-Pak a Division of the Belport, Jeff Nichols. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Purpose

Description

Inactive Ingredient

Keep out of reach if children

Storage

Uses

Do not use

Warnings

Directions

Principal Display-Orostat 8%

INGREDIENTS AND APPEARANCE

OROSTAT 8% 
epinephrine hydrochloride solution

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

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10129-006-02	15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/04/1990

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

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

Registrant - Jeff Nichols (008480121)

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