Australian Gold Defense Zone
FDA Label NDC 58443-0186

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 Defense Zone (NDC 58443-0186). 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 principal display panel - 59 ml  bottle label, active ingredient:, purpose, indications:, warning:, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Principal Display Panel - 59 Ml  Bottle Label

Defense

Zone

Medicated 

LEAVE-IN

TREATMENT

Anti-Dandruff

Step

3

Relieves Dryness

2 FL OZ (59mL)

Active Ingredient:

Pyrithione Zinc 0.22%

Purpose

Antidanruff

Indications:

  • Controls the symptoms of dandruff.
  • Helps prevent recurrence of scalp itching and flaking associated with dandruff.

Warning:

Otc - When Using

When using this product

  • Avoid contact with the eyes. If contact occurs, rinse eyes thorougly with water.

Otc - Stop Use

Stop use and ask a doctor

  • If condition worsens or does not improve after regular use of this product as directed.

Otc - Keep Out Of Reach Of Children

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 Ingrediets:

Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetrimonium Bromide, Cetyl Alcohol, Chlorphenesin, Citric Acid, Disodium EDTA, Elaeis Guineensis (Palm) Oil, Fragrance, Glycerin, Phenoxyethanol, Sodium Hydroxide, Stearyl Dihydroxypropyldisodium Oligosaccharides, Water

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