FDA Label for Atopalm Clotrimazole Antifungal

View Indications, Usage & Precautions

Atopalm Clotrimazole Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Neopharm Co., Ltd.. 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.

Other



Drug Facts

US Patent US 6221371B1

Distributed by: NeoPharm Co., Ltd, 80 Wood Rd, 212 Camarillo, CA 93010

Made in Korea

Clotrimazole 1%AntifungalCream

Otc - Active Ingredient



Active Ingredients

Clotrimazole 1%


Otc - Purpose



Purpose

Antifungal


Indications & Usage



Uses

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Warnings



Warnings       For external use only.


Otc - Do Not Use



Do not use on diaper rash or on children under 2 years of age unless directed by a doctor.



Otc - When Using



When using this product avoid contact with the eyes


Otc - Stop Use



Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ring worm) or 2 weeks (for jock itch).

Otc - Keep Out Of Reach Of Children



Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.


Dosage & Administration



Directions

  • wash affected area and dry thoroughly
  • apply a thin layer 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 toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day.
  • for athlete's foot and ringworm, use daily for 4 weeks, for jock itch use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product not effective on the scalp or nails

Storage And Handling



Other Information

  • store at 20 degrees to 25 degrees  (68 degrees to 77 degrees F)
  • see end of carton or tube crimp for lot number and expiration date

Inactive Ingredient



Inactive Ingredients

Water, Glycerin,Cetyl Alcohol, Mineral Oil, Glyceryl Stearate, PEG Glyceryl Stearate, Stearic Acid, Benzyl Alcohol, Carbomer 940, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Triethanolamine


Otc - Questions



Questions? Call 1-855-ATOPALM


Product Labeling





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