Healthy Accents Antifungal
FDA Label NDC 55316-829

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dza Brands Llc for the product Healthy Accents Antifungal (NDC 55316-829). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                 Purpose

Clotrimazole 1%...............................................................Antifungal

Otc - Purpose

Uses

  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use on children under 2 years of age unless directed by a doctor

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

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

Indications & Usage

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and chagne shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condtion persists longer, ask a doctor
  • this product is not effectiveo n the scalp or nails

Storage And Handling

Other information store between 20° to 25° (68° to 77°F)

Inactive Ingredient

Inactive ingredients

benzyl alcohol, cetanol, liquid paraffin, octyldodecanol, polysorbate 60, propylene glycol, purified water, sodium hydroxide, sorbitan monostearate, stearic acid, stearyl alcohol

Dosage & Administration

Distributed by:

Salisbury, NC 28147

Scarborough, ME 04074

Product of Korea

Package Label.Principal Display Panel

Image Description (98829)

Image Description (98829)

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