Label: VITASTEM- tetracycline hydrochloride ointment
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- NDC Code(s): 71262-002-00, 71262-002-15
- Packager: ViaDerma Distribution, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 22, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Indications:
- Warnings:
For external use only. May be harmful is swallowed.
Allergy Alert: Do not use if allergic to any ingredient listed on this label.
CloseKeep 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.
Close - Package Labeling:
- INGREDIENTS AND APPEARANCE
VITASTEM
tetracycline hydrochloride ointmentProduct 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 11/08/2016 CloseLabeler - ViaDerma Distribution, Inc. (081113521)
