TETRASTEM- tetracycline hydrochloride ointment 
VIADERMA II, 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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TetraStem - Topical Ointment

Drug Facts

Active ingredient (in each gram)

Tetracycline hydrochloride 30 mg

Purpose

First Aid Antibiotic

Use

First aid to help prevent skin infection in minor cuts, scrapes, and burns.

Warnings

For external use only. May be harmful if swallowed.
Allergy alert: Do not use if allergic to any ingredient listed on this label.

Do not use

  • in the 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 burns

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.

Other information

  • Keep product refrigerated to preserve its effectiveness and color
  • Stop use if product is misused: If the bottle is left open and/or if not refrigerated, the liquid will tend to turn black over time. Discard the product if the liquid turns black due to misuse.
  • 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, HYDROXETHYLCELLULOSE,
MAGNESIUM STEARATE, METHYLPARABEN, SODIUM
HYDROXIDE, SORBIC ACID, STEARIC ACID, WATER

Package Label

TetraStem
brand


Refrigerate
Topical
Ointment


First Aid
Antibiotic
Tetracycline
Hydrochloride


NET WT. 0.1 OZ (3 G)

Patent Pending                          
Alcohol free, no biological products
www.viadermalicensingcom.


Remove top of plastic box to read full contents of the
enclosed Drug Facts label. Plastic box top is not sealed.

Side effects
Same as other tetracycline products

Report any side effects to ViaDerma,Inc.

8950 W. Olympic Blvd #576, Beverly Hills, CA 90211 USA

Tel. 310-371-9996

Email: geraldnewmanesq@viadermalicensing.com

front

back

TETRASTEM 
tetracycline hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69006-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T) TETRACYCLINE HYDROCHLORIDE30 mg  in 1 g
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:69006-001-033 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/28/201412/09/2015
Labeler - VIADERMA II, INC. (079387584)
Establishment
NameAddressID/FEIBusiness Operations
Phillips Company612368238manufacture(69006-001)

Revised: 12/2015
 
VIADERMA II, INC.