ORAL-PRO SALICYLIC ACID WITH CAFFEINE- salicylic acid concentrate

ORAL-PRO SALICYLIC ACID by

Drug Labeling and Warnings

ORAL-PRO SALICYLIC ACID by is a Animal medication manufactured, distributed, or labeled by Aurora Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS:

A liquid salicylic acid concentrated solution with caffeine for use in animals.

INGREDIENTS:

Salicylic Acid . . . . . . . . . . . . 9.2% w/w

DIRECTIONS FOR USE:

Use between 1 and 32 ounces in 128 gallons of water, or 1 to 4 ounces per gallon of stock solution at 1:128.

WARNING:

Do not administer concentrated solution by direct oral administration — gastrointestinal irritation or overdose may occur.

STORAGE AND HANDLING

Store at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F). Do not freeze.

CAUTION:

Keep container closed when not in use. Salicylic Acid crystals may form at cold storage temperatures. Place bottle in warm water and gently invert to dissolve crystals. Do not use if allergic or sensitive to the active ingredients.

FLAMMABLE - USE WITH CAUTION

Consumer Commodity ORM-D

SPL UNCLASSIFIED SECTION

REORDER NO: 21005

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com
IN 50-1313 05/2013

MANUFACTURED IN THE USA

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

NDC: 51072-046-02

ORAL-PRO™

Salicylic Acid Concentrate with Caffeine

Contains Salicylic Acid (9.2%)

For Animal Use Only

KEEP OUT OF REACH OF CHILDREN

32 fl. oz. (946 ml)

AURORA PHARMACEUTICAL®

INGREDIENTS AND APPEARANCE

ORAL-PRO SALICYLIC ACID  WITH CAFFEINE
salicylic acid concentrate

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51072-046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	7.9 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51072-046-02	946 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/02/2013	04/30/2022

Labeler - Aurora Pharmaceutical, Inc. (832848639)

Establishment
Name	Address	ID/FEI	Business Operations
Aurora Pharmaceutical, Inc.		832848639	MANUFACTURE