Label: DERMACLINE- tetracycline hydrochloride ointment
- NDC Code(s): 71250-002-00
- Packager: Inventus, LLC
- 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.
Updated November 8, 2016
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- Active Ingredient (in each gram)
Tetracycline Hydrochloride 30mgClose
First Aid antibioticClose
First aid to help prevent skin infection in minor cuts, scrapes, and burns.Close
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.
- 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.Close
- Label- Dermacline Topical Ointment
- INGREDIENTS AND APPEARANCE
tetracycline hydrochloride ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71250-002 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71250-002-00 1 in 1 BOX 02/09/2017 1 5 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 Labeler - Inventus, LLC (080506784) Establishment Name Address ID/FEI Business Operations Inventus, LLC 080506784 manufacture(71250-002)