Double Antibiotic Ointment
FDA Label NDC 58980-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals Inc for the product Double Antibiotic (NDC 58980-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, allergy alert, when using this product, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

Otc - Purpose

Active ingredient (in each gram)Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Polymyxin B 10,000 unitsFirst aid antibiotic

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Do Not Use

  • in the eyes
  • over large areas of the body

Allergy Alert

  • do not use if allergic to any of the ingredients

When Using This Product

  • do not use longer then one week unless directed by doctor

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use And Ask A Doctor If

  • condition persists or gets worse
  • a rash or other allergic reaction develops

Directions

  • Clean the affected area
  • Apply a small amount of this product on the area 1 to 3 times
  • May be covered with a sterile bandage

Other Information

  • Store at room temperature
  • Before using any medication, read all label directions.

Inactive Ingredient

White petrolatum

Questions Or Comments?

Call toll-free 1-800-442-7882

Principal Display Panel - 0.9 G Packet Box

NDC 58980-012-01

STRATUSCARE
Double Antibiotic
Ointment

(Bacitracin Zinc and
Polymyxin B Sulfate Ointment USP)

First Aid Antibiotic

Distributed by:
STRATUS
PHARMACEUTICALS INC

1 GROSS

Net Wt. 0.9g (1/32 oz) PACKETTES

Principal Display Panel (0.9 g Packet Box)

Principal Display Panel (0.9 g Packet Box)

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