Occulus
FDA Label NDC 13630-0092

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 Packaging, Inc. for the product Occulus (NDC 13630-0092). 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 - 125 g can label, active ingredient, purpose, uses, warnings, 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 - 125 G Can Label

Principal Display Panel (125g Can Label)

Principal Display Panel (125g Can Label)

SKIN HYDRATING

TOPICAL FOAM

CLO-1

ANTIFUNGAL FOAM

Relief for itching

and burning feet


NET WT. 4.4 OZ (125g)

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • For the treatment of most athlete's foot (tinea pedis) or ringworm (tinea corporis).
  • For effective relief of redness, irritation, scaling, cracking, itching, burning feet.

Warnings

Otc - When Using

When using this product: • Avoid contact with the eyes. • Do not use on deep or puncture wounds, infections or lacerations.

Otc - Stop Use

Stop use and ask a doctor if

  • Irritation occurs or if there is no improvement within 4 weeks.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

  • Hold can upright. Shake well before each application.
  • 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 athlete'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 athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Inactive Ingredients

Water, Cetearyl ethylhexanoate, Butane, Propylene glycol, Palmitic acid, Propane, Stearic Acid, PVP, Polysorbate-20, Triethanolamine, Glycerin, Dimethicone, Tocopheryl Acetate, Disodium EDTA, Ubiquinone

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