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Rx Item-Altabax retapamulin 1% 30 GM Ointment by Aqua Pharma USA

Item No. RX563580, 563580, NDC No.: 16110-0518-30, 16110-518-30, 1611051830, 16110051830, 0518-30, 051830 UPC No. 3-16110-51830-5, 316110-518305, 316110518305Item No. RX563580, 563580, NDC No.: 16110-0518-30, 16110-518-30, 1611051830, 16110051830, 0518-30, 051830 UPC No. 3-16110-51830-5, 316110-518305, 316110518305Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

Rx Item-Altabax retapamulin 1% 30 GM Ointment by Aqua Pharma USA

$807.52$719.99

Rx Item-Altabax 1% retapamulin 30 GM Ointment by Aqua Pharma USA , Only Physician, Pharmacy Or Licensed Facility Can purchase this RX Item.Item No. RX563580, 563580, NDC No.: 16110-0518-30, 16110-518-30, 1611051830, 16110051830, 0518-30, 051830 UPC No. 3-16110-51830-5, 316110-518305, 316110518305Drug Category:Anti-Infectives-Topical Antibiotics Drug Class: Drug Class: 84040400 Antibacterials (Skin Mucous Membrane) Other Names:Retapamulin, Altabax

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Rx Item-Altabax 1% 30 GM Ointment by Aqua Pharma USA , Clinical Information:
Generic Code And Description: 62599 Retapamulin Topical Ointment (G) 1 %
Strength: 1 %
Dose Form: Ointment (Gram)
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 84040400 Antibacterials (Skin Mucous Membrane)
Active Ingredients: 12148 Retapamulin 224452668
Inactive Ingredients: Drug Class: Drug Class: 84040400 Antibacterials (Skin Mucous Membrane) , OMP Family: , Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 30GM, Brand Label Flag: BRANDBRAND , Storage Temperature Zone: 10 Room Temperature, Item Size Code:30GM, Item Strength Code:1% , Item Abbreviation: Altabax , Generic Form: ONT

These highlights do not include all the information needed to use ALTABAX safely and effectively. See full prescribing information for ALTABAX.

ALTABAX (retapamulin ointment), for topical use
Initial U.S. Approval: 2007

INDICATIONS AND USAGE

ALTABAX, a pleuromutilin antibacterial, is indicated for the topical treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes in patients aged 9 months or older. (1) Safety in patients younger than 9 months has not been established.

DOSAGE AND ADMINISTRATION

Apply a thin layer of ALTABAX to the affected area (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) twice daily for 5 days. (2)
The treated area may be covered with a sterile bandage or gauze dressing if desired. (2)

DOSAGE FORMS AND STRENGTHS

10 mg retapamulin per 1g of ointment (1%) in 15- and 30-gram tubes (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

Discontinue in the event of sensitization or severe local irritation. (5.1)
Not intended for ingestion. Not for intraoral, intranasal, ophthalmic, or intravaginal use. (5.2)

ADVERSE REACTIONS

The most common drug-related adverse reaction was application site irritation (less than or equal to 2% of subjects). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2023

Item No. RX563580, 563580, NDC No.: 16110-0518-30, 16110-518-30, 1611051830, 16110051830, 0518-30, 051830 UPC No. 3-16110-51830-5, 316110-518305, 316110518305
Rx Item-Altabax 1% 30 GM Ointment by Aqu
Item No. RX563580, 563580, NDC No.: 16110-0518-30, 16110-518-30, 1611051830, 16110051830, 0518-30, 051830 UPC No. 3-16110-51830-5, 316110-518305, 316110518305

Item No. RX563580, 563580, NDC No.: 16110-0518-30, 16110-518-30, 1611051830, 16110051830, 0518-30, 051830 UPC No. 3-16110-51830-5, 316110-518305, 316110518305
Rx Item-Altabax 1% 30 GM Ointment by Aqu
Item No. RX563580, 563580, NDC No.: 16110-0518-30, 16110-518-30, 1611051830, 16110051830, 0518-30, 051830 UPC No. 3-16110-51830-5, 316110-518305, 316110518305

Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica
Rx Item-Altabax 1% 30 GM Ointment by Aqu
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica