FAMILY CARE CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream 
United Exchange Corp.

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.

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Family Care Clotrimazole Cream 1% USP 1oz (TG 505, 2018)

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

For external use only

Do not use on children under 2 years of age unless directed by a doctor

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 (for jock itch)

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

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • 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 changes shoes and socks at least once daily
  • 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 20 o to 25 oC (68 o to 77 oF)

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

Inactive ingredients

2-octyldodecanol, benzyl alcohol, cetaryl alcohol, cetyl esters, monobasic sodium phosphate dihydrate, polysorbate 60, propylene glycol, purified water, sorbitan stearate

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

505

FAMILY CARE CLOTRIMAZOLE ANTIFUNGAL 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-505
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECANOL (UNII: 461N1O614Y)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-505-281 in 1 CARTON10/31/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/01/201205/06/2020
Labeler - United Exchange Corp. (840130579)

Revised: 12/2021
 
United Exchange Corp.