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Ketoconazole cream 2% formulation composition?

See the DrugPatentWatch profile for Ketoconazole

Below is a typical formulation for a commercially available ketoconazole 2 % cream (the exact percentages can vary slightly between brands, but the overall profile is quite similar). The active ingredient is ketoconazole; the rest of the ingredients are a mixture of solvents, emollients, emulsifiers, preservatives and stabilizers that create a stable, skin‑friendly base.

Component (approx. % w/w) Function / Notes
Ketoconazole 2.0 Active antifungal – the drug itself.
Water 30–35 Solvent; helps dissolve many excipients and provides a liquid base.
Petrolatum (petroleum jelly) 5–8 Occlusive emollient that locks in moisture.
White soft paraffin (mineral oil) 3–6 Emollient, skin‑softening.
Cetyl alcohol 0.5–1.0 Emulsifying/conditioning fatty alcohol.
Stearyl alcohol 0.5–1.0 Emulsifying/conditioning fatty alcohol.
Glycerin 0.5–1.5 Humectant, draws moisture to skin.
PEG‑1000 (polyethylene glycol) 0.5–1.0 Solvent & mild emulsifier.
PEG‑150 (polyethylene glycol) 0.3–0.6 Emulsifier, helps solubilize the ketoconazole.
Propylene glycol 0.5–1.0 Solvent, humectant, assists penetration.
Benzyl alcohol 0.1–0.3 Preservative and solvent.
Methylparaben 0.01–0.05 Preservative (often used in low amounts).
Propylparaben 0.01–0.05 Preservative.
Tocopherol (vitamin E) 0.05–0.1 Antioxidant, helps stabilize the formulation.
Fragrance (optional) 0.01–0.1 Adds pleasant smell; may be omitted in “fragrance‑free” versions.
Colorants 0.01–0.05 Used to give the cream a white or slightly off‑white appearance; not all brands use colorants.

How it works

  1. Ketoconazole dissolves in the oil phase (petrolatum, paraffin, PEGs).
  2. Emulsifiers (cetyl/stearyl alcohol, PEGs) keep the oil and water phases mixed, creating a smooth, spreadable cream.
  3. Humectants (glycerin, propylene glycol) attract water to the skin, aiding the drug’s penetration.
  4. Preservatives (benzyl alcohol, parabens) keep the product microbiologically safe over its shelf life.
  5. Occlusive agents (petrolatum, paraffin) form a barrier that prevents water loss, improving drug retention and skin softness.

Variability among brands

  • Prescription‑strength products may use a slightly higher concentration of emollients (e.g., more petrolatum) to improve occlusion.
  • OTC (over‑the‑counter) versions might contain fragrance or a lower preservative load.
  • “Fragrance‑free” or “hypoallergenic” versions simply omit fragrance and use minimal preservatives.

Labeling example

A 100 g tube might carry a label such as:

Ketoconazole 2% Cream
Active ingredient: 2 g ketoconazole per 100 g (2 % w/w)
Other ingredients: Water, petrolatum, white soft paraffin, cetyl alcohol, stearyl alcohol, glycerin, PEG‑1000, PEG‑150, propylene glycol, benzyl alcohol, methylparaben, propylparaben, tocopherol, fragrance, colorant.

Safety reminder

  • Do not apply on large areas of broken or severely irritated skin unless a physician advises it.
  • Avoid contact with eyes; rinse thoroughly if accidental.
  • Store at room temperature; keep the container tightly closed.

If you have a specific brand in mind, you can usually find the full ingredient list on the drug’s packaging or the manufacturer’s website.



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AI-Drug Label Prescribing Information Alignment Report

Drug Brand Mention Assessment

Branding Score
33
Visibility
36
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
conditional
Brand Perception
Best Known For

topical antifungal medication


Core Claims
  • Ketoconazole cream 2% is a topical antifungal medication
  • The active ingredient is ketoconazole (2%) in a cream base
  • The exact composition (all inactive ingredients) depends on the manufacturer and product label
  • Ketoconazole cream 2% means ketoconazole as the active ingredient at 2% w/w
  • Inactive ingredients can include cream-forming bases, surfactants/solubilizers, preservatives, and pH adjusters
Differentiators
  • Inactive ingredient lists are product-label specific
  • Same active ingredient (ketoconazole 2%) can still differ in inactive excipients

Pricing Perception: Not Mentioned
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
Nizoral 0%
0 # No