Orostat Solution

SPL v1

SPL

SPL Set ID 755005b8-165b-b667-e053-2991aa0a3651

Routes

SUBGINGIVAL PERIODONTAL DENTAL

Published

Effective Date 2018-09-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Epinephrine (1200 mg)

Inactive Ingredients

Sodium Dithionite Sodium Thiosulfate Sodium Phosphate, Monobasic, Anhydrous Sodium Chloride Propylparaben Benzyl Alcohol Edetic Acid Methylparaben

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 1990-04-04

Medication Information

Purpose

Description

Uses

Storage

Warnings

Directions

Do Not Use

Active Ingredient

Inactive Ingredient

Principal Display Orostat 8%

Keep Out of Reach If Children

Structured Label Content

Uses

Purpose

Storage

Warnings

Directions

Do Not Use (Do not use)

Description

Active Ingredient

Inactive Ingredient

Principal Display Orostat 8% (Principal Display-Orostat 8%)

Keep Out of Reach If Children (Keep out of reach if children)

Advanced Ingredient Data

[{"name": "EPINEPHRINE", "unii": "YKH834O4BH", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM DITHIONITE", "unii": "2K5B8F6ES1", "classCode": "IACT", "strengthNumerator": "37.5", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM THIOSULFATE", "unii": "HX1032V43M", "classCode": "IACT", "strengthNumerator": "15", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS", "unii": "KH7I04HPUU", "classCode": "IACT", "strengthNumerator": "37.5", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "49.5", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "4.95", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "0.15", "strengthDenominator": "15", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "IACT", "strengthNumerator": "1.995", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "10.05", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:38.687735 · Updated: 2026-03-14T22:55:16.609561