1. Home
  2. Labeler Index
  3. Lifelabs, A Division Of Atico International Usa, Inc.
  4. 51852-103
  5. Label Information: Clotrimazole

FDA Label for Clotrimazole

View Indications, Usage & Precautions

Table of Contents

    1. CLOTRIMAZOLE
    2. OTC - PURPOSE
    3. WARNINGS
    4. INDICATIONS & USAGE
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. STORAGE AND HANDLING
    9. INACTIVE INGREDIENT
    10. OTC - QUESTIONS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clotrimazole Product Label

The following document was submitted to the FDA by the labeler of this product Lifelabs, A Division Of Atico International Usa, 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.

Clotrimazole



Active Ingredient

Clotrimazole 1%


Otc - Purpose



Purpose

Antifungal

Uses

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

Warnings



Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.


Indications & Usage



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 ringworm) or 2 weeks (for jock itch)
  • do not use for diaper rash

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


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 the 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 conditions persist longer, ask a doctor
  • this product is not effective on the scalp or nails

Storage And Handling



Other information

store between 2o and 30o C (30o and 86o F) Lot No. and Exp. Date: see box or see crimp of tube


Inactive Ingredient



Inactive ingredients

benzyl alcohol, isopropyl myristate, liquid parafin, polysorbate 60, propylene glycol, purified water, stearic acid, stearyl aclohol, sorbitan monostearate


Otc - Questions



Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.


Package Label.Principal Display Panel








* Please review the disclaimer below.