Hydrocortisonedrug info
hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic Suspension
What it is used for
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 24, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP is a sterile antibacterial and anti-inflammatory suspension for otic use.
Each mL contains: Actives: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%);
Inactives: cetyl alcohol (0.9%), polysorbate 80, propylene glycol, purified water. Sulfuric acid may be added to adjust pH (3.0 - 7.0).
Preservative: thimerosal 0.01%. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis.
The structural formulae are: Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis.
The structural formulae are: Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone.
Its structural formula is: ChemS ChemSt ChemStr
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 24, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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