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  5. Label Information: Athletes Foot

FDA Label for Athletes Foot

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTSACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS:
    5. WARNINGS:
    6. DIRECTIONS:
    7. INACTIVE INGREDIENTS:
    8. ATHLETE'S FOOT CREAM PRODUCT LABEL

Athletes Foot Product Label

The following document was submitted to the FDA by the labeler of this product Blaine Labs 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.

Drug Factsactive Ingredient



Undecylenic Acid 25%


Purpose



Antifungal


Keep Out Of Reach Of Children



Keep this and all drugs out of reach of children. In case of accidential ingestion, seek professional assistance, or contact aa poison control center immediately.


Indications:



Cures Althete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris) and Ringworm (Tinea Corporis). For effective relief of itching, cracking, burning, and discomfort, which can accompany these conditions.


Warnings:



Do not use on children under two years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch), discontinue use and consult a physician.  


Directions:



Wash the affected area with soap and water and dry thoroughly. Apply sparingly over affected area twice daily (morning and night), or as directed by a physician. For Athlete's Foot, pay special attentionto 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 four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician.


Inactive Ingredients:



Water, Hydroxyenthylcellulose, Aloe Barbadensis (Aloe) Leaf Juice, Urea, Disodium EDTA, Coco Caprylate/Caprate, Polysorbate 60, PEG-100 Stearate, Cetyl Alcohol, Glyceryl Stearate, Stearic Acid, Methylparaben, Propylparaben, Sodium Polyacrylate, Hydrogenated Polydecene, Ultramarines, Menthol, Oregano Oil, Peppermint Oil, Triethanolamine


Athlete's Foot Cream Product Label



NDC: 63347-205-01

Athlete's Foot Cream

PRACTICE EXCLUSIVE


Undecylenic Acid 25%

Jojoba Bead technology

2.0 FL OZ

Manufactured by: Blaine Labs, Inc., 11037

Lockport Place, Santa Fe Springs, CA 90670


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