TETRACYCLINE 3 PERCENT A FIRST AID ANTIBIOTIC- tetracycline hydrochloride ointment
Patient Focused Tele-Health, 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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Tetracycline 3 % a First Aid Antibiotic Ointment

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

longer than 1 week unless directed by a doctor
in the eyes
over large areas of the body

Ask a doctor before use if you have

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

Stop use and ask a 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.
Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.
May be covered with a sterile bandage.

Inactive ingredients

Ascorbic Acid, Aloe Barbadensis Leaf Juice, Carbomer, Cholecalciferol, Citric Acid, Diazolidinyl Urea, Dimethyl Sulfoxide, Dipropylene Glycol, DMDM Hydantoin, Glycerine, Polysorbate 20, Sodium Dodecylbenzene Sulfonate, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolamine, Water

Package Labeling:

TETRACYCLINE 3 PERCENT A FIRST AID ANTIBIOTIC
tetracycline hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72053-000
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE SODIUM (UNII: MP1J8420LU)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYDANTOIN (UNII: I6208298TA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72053-000-00	1 in 1 BOX	04/01/2018
1		3 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	04/01/2018

Labeler - Patient Focused Tele-Health, LLC (081008911)

Name	Address	ID/FEI	Business Operations
Establishment
TG Labs, Inc.		831504621	manufacture(72053-000)

Revised: 10/2022

Document Id: eac73ae4-22f0-7d2e-e053-2995a90a311f

Set id: 647918a1-f49f-ef01-e053-2a91aa0a11fb

Version: 7

Effective Time: 20221011

Patient Focused Tele-Health, LLC