VIABECLINE- tetracycline hydrochloride ointment

Viabecline by

Drug Labeling and Warnings

Viabecline by is a Otc medication manufactured, distributed, or labeled by Accuria, LLC, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Activer 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. May be harmful if swallowed.

Allergy Alert: Do not use if allergic to any ingredient listed on this label.

Do not use

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

Ask  doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if the condition persists or gets worse.

KEEP OUT OF REACH OF CHILDREN

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.

Other information

• Keep product refrigerated to preserve its effectiveness and color
• Stop use if the product is misused: If the bottle is left open and or not refrigerated, the liquid will tend to turn black over time. Discard the product if the liquid turns black due to misuse.
• This product is an OTC antibiotic for human use.
• Contains no alcohol, no animal ingredients.
• Blended for typical skin color.
• May stain cloth.
• No claims regarding stem cell healing are implied for this product.

Inactive Ingredients

ACETIC ACID, ASCORBIC ACID, CHLORHEXIDINE GLUCONATE, CHOLECALCIFEROL, DIMETHYL SULFOXIDE, DIPROPYLENE GLYCOL, GLUCONO DELTA LACTONE, GLYCERIN, HISTIDINE, HYDROXETHYL-CELLULOSE, MAGNESIUM STEARATE, METHYLPARABEN, SODIUM HYDROXIDE, SORBIC ACID, STEARIC ACID, WATER

Package Label: 71491-100-00 VIABECLICNE 5 ML Package Label: 71491-100-01 VIABECLINE 15ML

INGREDIENTS AND APPEARANCE

VIABECLINE 
tetracycline hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71491-100
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
ACETIC ACID (UNII: Q40Q9N063P)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HISTIDINE (UNII: 4QD397987E)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71491-100-01	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/15/2017
2	NDC: 71491-100-00	5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	06/14/2017

Labeler - Accuria, LLC (080520669)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(71491-100)