TETRANEXT- tetracycline hydrochloride ointment 
Saxet Pharmaceuticals

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.

----------

TetraNext™

Drug Facts

Active Ingredient

Tetracycline hydrochloride 3%

Purpose

First aid antibiotic ointment

Uses

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

Warnings

For external use only

Do not use

  • in the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
  • Longer than 1 week unless directed by a physician

Ask a physician before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a physician if

  • condition persists or gets worse
  • rash or other allergic reaction occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Water, glycerin, hydroxethylcellulose, chlor-hexide gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid

Questions or comments?

Call 1-866-957-2938

PRINCIPAL DISPLAY PANEL - 0.3 mL Vial Carton

SAXET | PHARMACEUTICALS

TetraNext

Tetracycline HCl 3% | First Aid Ointment

MAXIMUM INFECTION PROTECTION

20 single-use vials - 0.3 mL each
NDC 70598-001-20

PRINCIPAL DISPLAY PANEL - 0.3 mL Vial Carton
TETRANEXT 
tetracycline hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70598-001
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
Water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
hydroxymethyl cellulose (UNII: 273FM27VK1)  
chlorhexidine gluconate (UNII: MOR84MUD8E)  
gluconolactone (UNII: WQ29KQ9POT)  
methylparaben (UNII: A2I8C7HI9T)  
sodium hydroxide (UNII: 55X04QC32I)  
dipropylene glycol (UNII: E107L85C40)  
dimethyl sulfoxide (UNII: YOW8V9698H)  
sorbic acid (UNII: X045WJ989B)  
ascorbic acid (UNII: PQ6CK8PD0R)  
magnesium stearate (UNII: 70097M6I30)  
stearic acid (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorBROWN (Light brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70598-001-2020 in 1 CARTON08/01/2016
10.3 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:70598-001-055 in 1 CARTON08/01/2016
20.3 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B08/01/2016
Labeler - Saxet Pharmaceuticals (080032028)

Revised: 2/2017
Document Id: bbc9d8c6-6b15-41fd-84f0-cb61f2d7e028
Set id: d277e34c-bf05-42a4-9bbf-860cba62d060
Version: 2
Effective Time: 20170203
 
Saxet Pharmaceuticals