Active Ingredients
Pyrithione Zinc 0.22%
Australian Gold
FDA Label NDC 58443-0243
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises Inc. for the product Australian Gold (NDC 58443-0243). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, indications, warnings, when using this product, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antidandruff
Indications
- Controls the symptoms of dandruff.
- Helps prevent recurrence of scalp itching and flaking associated with dandruff.
Warnings
For external use only.
When Using This Product
- Avoid contact with the eyes. If contact occurs, rinse eyes thouroughly with water.
Stop Use And Ask A Doctor
- If condition worsens or does not improve after regular use of this product as directed.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Shake well
- Use after shampooing and towel drying hair. Part hair section by section. Apply directly onto the scalp and spread using fingertips. Gently massage into scalp. Leave in.
- Apply to affected areas one to four times daily or as directed by a doctor.
- Children under 6 months of age: ask a doctor.
Inactive Ingredient
Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetrimonium Bromide, Cetyl Alcohol, Chlorphenesin, Disodium EDTA, Elaeis Guineensis (Palm) Oil, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Stearyl Dihydroxypropyldimonium Oligosaccharides, Water, may contain Citric Acid, may contain Sodium Hydroxide
Other Information
- Protect from heat.
Questions Or Comments?
Call toll free 1-855-548-4653
Australian Gold Metro 365 Medicated Leave-In Treatment Step 3
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