VITASTEM- tetracycline hydrochloride ointment 
ViaDerma Distribution, Inc.

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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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.

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:

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 finalpart333B11/08/2016
Labeler - ViaDerma Distribution, Inc. (081113521)

Revised: 3/2019
Document Id: 85142e7a-6441-6740-e053-2991aa0ac3b5
Set id: a6630858-7038-425f-8a75-bb25f36a0dbe
Version: 5
Effective Time: 20190327
 
ViaDerma Distribution, Inc.