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Monday, March 20, 2017 2:47:11 PM
https://www.drugs.com/otc/676986/viabecline.htm
Viabecline
Dosage form: ointment
Ingredients: TETRACYCLINE HYDROCHLORIDE 30mg in 1mL
Labeler: VIADERMA II, INC.
NDC Code: 69006-002
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.
Viabecline Topical Ointment
Active Ingredient (in each gram)
Tetracycline Hydrochloride 30mg
Purpose
First Aid antibiotic
Use
First aid to help prevent skin infection in minor cuts, scrapes, and burns.
Warnings
For esternam 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 our 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 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 Ingredient
Acetic Acid, Ascorbic Acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, GLYCERIN, histidine, hydroxethylc-cellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, steric acid, water.
Label- Viabecline Topical Ointment
VIABECLINE
tetracycline hydrochloride ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69006-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE) TETRACYCLINE HYDROCHLORIDE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
ASCORBIC ACID
CHLORHEXIDINE GLUCONATE
CHOLECALCIFEROL
DIMETHYL SULFOXIDE
DIPROPYLENE GLYCOL
GLYCERIN
HISTIDINE
MAGNESIUM STEARATE
METHYLPARABEN
SODIUM HYDROXIDE
SORBIC ACID
WATER
Packaging
# Item Code Package Description
1 NDC:69006-002-00 1 BOTTLE in 1 BOX
1 5 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 11/08/2016
Labeler - VIADERMA II, INC. (079387584)
Registrant - VIADERMA II, INC. (079387584)
Revised: 11/2016
VIADERMA II, INC.
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