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Athlete s Foot Afac

Dosage form: cream
Ingredients: Clotrimazole 0.01g in 1g
Labeler: Natureplex, LLC
NDC Code: 67234-009

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.

Athlete s Foot
Afac

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

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 right away.

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 change 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 condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information
  • store between 15°- 30°C (59°- 86°F)
  • do not use if seal on tube is punctured or missing

Inactive ingredients

Aloe barbadensis (aloe) leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl monostearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate 20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

call 866-323-0107 or visit www.natureplex.com

PRINCIPAL DISPLAY PANEL - 35 g Tube Carton

Natureplex

Athlete's Foot
clotrimazole cream

NET WT. 1.25 Oz. (35g)

ATHLETE S FOOT  AFAC
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (Clotrimazole) Clotrimazole0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CETYL ALCOHOL 
DMDM HYDANTOIN 
GLYCERYL MONOSTEARATE 
ISOPROPYL ALCOHOL 
METHYLPARABEN 
MINERAL OIL 
PROPYLPARABEN 
WATER 
STEARIC ACID 
TRIETHANOLAMINE DODECYLBENZENESULFONATE 
EDETATE TRISODIUM 
POLYSORBATE 20 
Packaging
#Item CodePackage Description
1NDC:67234-009-0135.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/22/2008
Labeler - Natureplex, LLC (062808196)
Establishment
NameAddressID/FEIOperations
Natureplex, LLC062808196manufacture(67234-009)

Revised: 08/2015
 
Natureplex, LLC

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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