1. Home
  2. Labeler Index
  3. Prime Packaging, Inc.
  4. 13630-0090
  5. Label Information: Occulus Skin Hydrating Topical Foam Clo-1 Antifungal Foam

FDA Label for Occulus Skin Hydrating Topical Foam Clo-1 Antifungal Foam

View Indications, Usage & Precautions

Table of Contents

    1. PRINCIPAL DISPLAY PANEL - 125G CAN LABEL
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS: FOR EXTERNAL USE ONLY
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS WATER, CETEARYL ETHYLHEXANOATE, PROPYLENE, GLYCOL, BUTANE, PALMITIC ACID, STEARIC ACID, PROPANE, PVP, POLYSORBATE-20, TRIETHANOLAMINE, GLYCERIN, DIMETHICONE, TOCOPHERYL ACETATE, DISODIUM EDTA, UBIQUINONE

Occulus Skin Hydrating Topical Foam Clo-1 Antifungal Foam Product Label

The following document was submitted to the FDA by the labeler of this product Prime Packaging, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Principal Display Panel - 125G Can Label



PRINCIPAL DISPLAY PANEL - 177mL Can Label - 13630 0090 3

PRINCIPAL DISPLAY PANEL - 177mL Can Label - 13630 0090 3

SKIN HYDRATING

TOPICAL FOAM

CLO-1

ANTIFUNGAL FOAM

Relief for itching

and burning feet

Helps support

skin barrier function

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: For External Use Only




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 wihin 4 weeks.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately. 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, Propylene, Glycol, Butane, Palmitic Acid, Stearic Acid, Propane, Pvp, Polysorbate-20, Triethanolamine, Glycerin, Dimethicone, Tocopheryl Acetate, Disodium Edta, Ubiquinone




* Please review the disclaimer below.