Altabax (Page 4 of 4)

15 REFERENCES

  1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Eleventh Edition. CLSI document M07-A11. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2018.
  2. CLSI. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-ninth Edition. CLSI supplement M100-S29. Wayne, PA: Clinical Laboratory Standards Institute; 2019.
  3. CLSI. Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Thirteenth Edition. CLSI Document M02-A13. Wayne, PA: Clinical Laboratory Standards Institute; 2018.

16 HOW SUPPLIED/STORAGE AND HANDLING

ALTABAX is supplied in 15-gram and 30-gram tubes.

NDC 16110-518-15 (15-gram tube)

NDC 16110-518-30 (30-gram tube)

Store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).

17 PATIENT COUNSELING INFORMATION

Patients using ALTABAX and/or their guardians should receive the following information and instructions:

  • Use ALTABAX as directed by the healthcare practitioner. As with any topical medication, patients and caregivers should wash their hands after application if the hands are not the area for treatment.
  • ALTABAX is for external use only. Do not swallow ALTABAX or use it in the eyes, on the mouth or lips, inside the nose, or inside the female genital area.
  • The treated area may be covered by a sterile bandage or gauze dressing, if desired. This may also be helpful for infants and young children who accidentally touch or lick the lesion site. A bandage will protect the treated area and avoid accidental transfer of ointment to the eyes or other areas.
  • Use the medication for the full time recommended by the healthcare practitioner, even though symptoms may have improved.
  • Notify the healthcare practitioner if there is no improvement in symptoms within 3 to 4 days after starting use of ALTABAX.
  • ALTABAX may cause reactions at the site of application of the ointment. Inform the healthcare practitioner if the area of application worsens in irritation, redness, itching, burning, swelling, blistering, or oozing.

ALTABAX is a registered trademark of Almirall, S.A.

Almirall

Manufactured for: Almirall, LLC, Malvern, PA 19355 © 2019 Almirall, LLC. All rights reserved.

PRINCIPAL DISPLAY PANEL — NDC: 16110-518-15 — 15 g Tube Label

15 g Tube Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 16110-518-15 — 15 g Carton Label

15 g Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 16110-518-30 — 30 g Tube Label

30 g Tube Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 16110-518-30 — 30 g Carton Label

30 g Carton Label
(click image for full-size original)

ALTABAX retapamulin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16110-518
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RETAPAMULIN (RETAPAMULIN) RETAPAMULIN 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16110-518-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (16110-518-15)
2 NDC:16110-518-30 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (16110-518-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022055 05/01/2016
Labeler — Almirall, LLC (605425912)

Revised: 06/2023 Almirall, LLC

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