DERMACLINE- tetracycline hydrochloride ointment 
Inventus, LLC

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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Dermacline

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

Ask a doctor before use if you have

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

Other Information

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- Dermacline Topical Ointment

image description

DERMACLINE 
tetracycline hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71250-002
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
HISTIDINE (UNII: 4QD397987E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71250-002-001 in 1 BOX02/09/2017
15 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 - Inventus, LLC (080506784)
Establishment
NameAddressID/FEIBusiness Operations
Inventus, LLC080506784manufacture(71250-002)

Revised: 11/2016
Document Id: a98f3fa6-855b-4cbb-ba33-90bdd7e521b1
Set id: 2601650a-1870-4fe5-9931-842fb2381c94
Version: 2
Effective Time: 20161108
 
Inventus, LLC