VITASTEM- tetracycline hydrochloride ointment 
ViaDerma Distribution, Inc.

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Vitastem

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.

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

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:

Stop use if product is misused

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:

Label

VITASTEM-tetracycline hydrochloride ointment, 60 ml (71262-002-01)

Label2

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

Label3Box

VITASTEM 
tetracycline hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71262-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71262-002-001 in 1 BOX02/09/2017
15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:71262-002-151 in 1 BOX07/01/2017
215 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:71262-002-011 in 1 BOX11/08/2016
360 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:71262-002-021 in 1 BOX11/08/2016
4100 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00411/08/2016
Labeler - ViaDerma Distribution, Inc. (081113521)

Revised: 12/2023
Document Id: 0b6df51f-3181-aaa3-e063-6294a90afc3c
Set id: a6630858-7038-425f-8a75-bb25f36a0dbe
Version: 6
Effective Time: 20231201
 
ViaDerma Distribution, Inc.