VITASTEM- tetracycline hydrochloride ointment

Vitastem by

Drug Labeling and Warnings

Vitastem by is a Otc medication manufactured, distributed, or labeled by ViaDerma Distribution, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Tetracycline-HCI 30mg

Purpose

First Aid/Antibiotic

Indications:

First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns

Warnings:

For external use only. May be harmful is swallowed.

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

Do not use

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

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious trauma

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.

Stop use if product is misused

• 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 Labeling:

VITASTEM-tetracycline hydrochloride ointment, 60 ml (

71262-002-01)

VITASTEM-tetracycline hydrochloride ointment, 100 ml (71262-002-02

INGREDIENTS AND APPEARANCE

VITASTEM 
tetracycline hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71262-002
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)
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: 71262-002-00	1 in 1 BOX	02/09/2017
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71262-002-15	1 in 1 BOX	07/01/2017
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 71262-002-01	1 in 1 BOX	11/08/2016
3		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 71262-002-02	1 in 1 BOX	11/08/2016
4		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	11/08/2016

Labeler - ViaDerma Distribution, Inc. (081113521)