ABRASA- tetracycline hydrochloride spray

Abrasa by

Drug Labeling and Warnings

Abrasa by is a Otc medication manufactured, distributed, or labeled by Azimuth Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each gram)

Tetracycline hydrochloride 30 mg

Purpose

First aid Antibiotic

Use

• First aid to help prevent skin infection in minor cuts, scrapes, and burns.

Warnings

For external use only

Do not use

• In the eyes or apply over large areas of the body
• Longer than 1 week unless directed by a doctor

Ask a doctor before use if

you have deep or puncture wounds, animal bites, or serious burns.

Stop use and ask doctor if

condition persists or gets worse.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the affected area
• Spray a small amount of this product on the area 1 to 3 time daily
• May be covered with a sterile bandage

Other information

• Keep product refrigerated to preserve its effectiveness and color
• Stop use if product is misused: if the bottles is left open and/or if not refrigerated, the liquid will tend to turn black over time.
• Contains no alcohol, no animal ingredient.
• Blender for typical skin color.
• May stain cloth.

Inactive ingredients

Citric Acid, Dimethyl Sulfoxide, Fulvic Acid, Water, Zinc Oxide

Package Labeling:

INGREDIENTS AND APPEARANCE

ABRASA 
tetracycline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81489-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)	TETRACYCLINE HYDROCHLORIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
FULVIC ACID (UNII: XII14C5FXV)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81489-001-01	29.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/30/2021

Labeler - Azimuth Pharma, LLC (032996180)