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.

CLOTRIMAZOLE LABEL

Clotrimazole 1%

Antifungal

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

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 eyes

  •  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.

  • wash affected area and dry thoroughly
  • apply a thin layer over the 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 and nails

  • Store between 15 and 30 C (59 and 86 F)
  • Do not use if seal on tube is punctured or missing

Carbomer, cetyl alcohol, DMDM Hydantoin, glyceryl stearate, methylparaben, mineral oil, polysorbate 20, propylparaben, stearic acid, triethanolamine, trisodium edta, water

ATHLETE'S FOOT PACKAGE LABEL

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
Carbomer Homopolymer Type C0.0034 g  in 1 g
cetyl alcohol0.035 g  in 1 g
DMDM Hydantoin0.0021 g  in 1 g
glyceryl monostearate0.0207 g  in 1 g
methylparaben0.0015 g  in 1 g
mineral oil0.031 g  in 1 g
polysorbate 200.0005 g  in 1 g
propylparaben0.001 g  in 1 g
stearic acid0.036 g  in 1 g
trolamine0.0104 g  in 1 g
edetate trisodium0.0026 g  in 1 g
water0.8358 g  in 1 g
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

Revised: 01/2012
 
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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