Simplyvital Antifungal Clotrimazole Cream
FDA Label NDC 82460-990

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alpha Plants Inc for the product Simplyvital Antifungal Clotrimazole (NDC 82460-990). 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 drug facts, active ingredient, purpose, uses:, warnings:, do not use, when using this product, discontinue use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Clotrimazole 1.00%

Purpose

Antifungal

Uses:

  • effective in the treatment of most athlete's foot, jock itch and ringworm.
  • for effective relief of itching, scaling, burning, soreness, irritation and doscomfort.

Warnings:

For external use only.

Do Not Use

  • on children under 2 years of age unless directed by a doctor

When Using This Product

  • Avoid contact with the eyes

Discontinue Use And Ask A Doctor If

  • irritation occurs.
  • condition persists.
  • there is no improvement of athelete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions:

  • clean the affected area and dry thoroughly.
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • supervise children in the use of this product.
  • for athelete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • for athelete's foot and ringworm, use daily for 4 weeks.
  • for jock itch, use daily for 2 weeks.
  • if condition persists longer, consult a doctor.
  • this product is not effective on the scalp or nails.

Other Information:

  • protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Ester, Cetyl Stearate, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel), Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Sorbitan Stearate, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Questions?

+1 (657) 999-7635

Package Labeling:

Box (Box)

Box (Box)

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