FAMILY CARE CLOTRIMAZOLE ANTIFUNGAL

Dosage form: cream
Ingredients: CLOTRIMAZOLE 1g in 100g
Labeler: UNITED EXCHANGE CORP
NDC Code: 65923-505

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient                                                                         Purpose

Clotrimazole 1% ........................................................................Antifungal

Uses

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

Warnings

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

For external use only

When using this product avoid contact with the eyes

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 (jock itch)
  • do not use for diaper rash

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 sock 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

Other information

Store between 20o to 25oC (68o to 77oF)

Lot No. and Exp. Date: see box or see crimp of tube

Inactive ingredients

Benzyl Alcohol, Isopropyl myristate, Liquid paraffin, Polysorbate 60, Propylene Glycol, Purified Water, Sorbitan Monostearate, Stearic Acid, Stearyl Alcohol

Distributed by:

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

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FAMILY CARE CLOTRIMAZOLE ANTIFUNGAL 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-505
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
PROPYLENE GLYCOL 
STEARIC ACID 
MINERAL OIL 
POLYSORBATE 60 
SORBITAN MONOSTEARATE 
BENZYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:65923-505-281 TUBE (TUBE) in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/01/2012
Labeler - UNITED EXCHANGE CORP (840130579)

Revised: 05/2012
 
UNITED EXCHANGE CORP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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