Shailee Antifungal Cream
FDA Label NDC 87995-001

7 label sections · Submitted to the FDA by Skinley Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skinley Llc for the product Shailee Antifungal Cream (NDC 87995-001). 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 ingredient:, purpose:, uses:, caution:, inactive ingredients:, other information:, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

Clotrimazole 1%

Purpose:

Antifungal

Uses:

  • Treats athlete's foot, jock itch, and ringworm.
  • Relieves itching, burning, cracking, and scaling associated with fungal skin infections.
  • Helps soothe and moisturize dry, irritated skin.
  • Use twice daily, in the morning and evening, or as directed by a healthcare professional.

    • DIRECTIONS FOR USE:

    • Cleanse and dry the affected area thoroughly.
    • Apply a thin layer of Cream to the affected skin.
    • Gently massage until fully absorbed.
    • Use once or twice daily, or as directed by a healthcare professional.
    • For best results, use consistently. Wash hands after application.

Caution:

For external use only.

Avoid contact with eyes.

If contact occurs, rinse thoroughly with water. Perform a patch test before first use.

Discontinue use if irritation occurs.

Keep out of reach of children.

Inactive Ingredients:

Water, Aloe Vera Leaf Extract, Tea Tree Oil, Lavender Oil, Calendula Extract, Witch Hazel Extract, Dimethicone, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Phenoxyethanol, Ethylhexylglycerin, Vitamin E.

Other Information:

  • Store in a cool, dry place between 20°C and 25°C (68°F to 77°F).
  • Refer to the bottom of the package for batch number and expiration date.
  • Keep away from direct sunlight and excessive heat.
  • Close the pump/cap tightly after each use to maintain product quality and stability

Product Label

Image Description (Label)

Image Description (Label)

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