Abrasa by Azimuth Pharma, LLC Abrasa Wound 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]

ABRASA- tetracycline hydrochloride spray 
Azimuth Pharma, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Abrasa Wound Spray

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

• Stop use if product is misused: if the bottles is left open the liquid will tend to turn dark over time.
• Contains no alcohol, no animal ingredients.
• Blended for typical skin color.
• May stain cloth.

Inactive ingredients

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

Package Labeling:

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	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	01/30/2021

Labeler - Azimuth Pharma, LLC (032996180)

Establishment
Name	Address	ID/FEI	Business Operations
Yellow Emperor Inc.		079862002	manufacture(81489-001)

Revised: 10/2022

Document Id: eb90c7be-e35f-351e-e053-2995a90aeaeb

34390-5

Set id: ba73db52-12cc-0e88-e053-2a95a90ac25a

Version: 3

Effective Time: 20221021