Erythromycin (Page 2 of 2)

Principal dispaly panel-Label

NDC 42571-384-25

Erythromycin Topical Solution, USP 2%

For Topical Use Only

Not for Ophthalmic Use

Rx only

60 mL

Principal dispaly panel-Carton

NDC 42571-384-25

Erythromycin Topical Solution, USP 2%

For Topical Use Only

Not for Ophthalmic Use

Rx only

60 mL

ERYTHROMYCIN erythromycin solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-384 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERYTHROMYCIN (ERYTHROMYCIN) ERYTHROMYCIN 20 mg in 1 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL ANHYDROUS CITRIC ACID PROPYLENE GLYCOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42571-384-25 1 BOTTLE in 1 CARTON contains a BOTTLE 1 60 mL in 1 BOTTLE This package is contained within the CARTON (42571-384-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062687 06/04/2021

Labeler — MICRO LABS LIMITED (862174955)

Registrant — Saptalis Pharmaceuticals, LLC. (080145868)

Establishment
Name	Address	ID/FEI	Operations
Saptalis Pharmaceuticals, LLC.		080145868	manufacture (42571-384)

Revised: 06/2021 MICRO LABS LIMITED