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CLOTRIMAZOLE by GRAXCELL PHARMACEUTICAL, LLC.

Medically reviewed on December 4, 2017

Dosage form: solution
Ingredients: CLOTRIMAZOLE 1g in 1mL
Labeler: GRAXCELL PHARMACEUTICAL, LLC.
NDC Code: 70795-8020

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 (TOPICAL SOLUTION) USP, 1%

DRUG FACTS

ACTIVE INGREDIENT

CLOTRIMAZOLE USP, 1%

PURPOSE

ANTIFUNGAL

USES

Cures most

  • Athlete's foot (tinea pedis)
  • Jock Itch (tinea cruris)
  • Ringworm (tinea corporis)

Effectively relieves

  • itching
  • cracking
  • burning

Discomfort which can accompany these conditions

warnings
  • For external use only

Ask a doctor before use

on children under 2 years of age

When using this product

avoid contact with eyes

Stop use and ask a doctorif

  • 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

This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product 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; change shoes and socks at least once daily.

other information
  • Store at 15°to 30°C (59° to 86°F)

inactive ingredients

polyethylene glycol 400

questions?

please call 1-888-266-8818

PRINCIPAL DISPLAY PANEL-10ML BOTTLE CARTON

NDC 70795-8020-1

GRAXCELL PHARMACEUTICAL, LLC.

Compare to the active ingredient of Lotrimin®AF*

10ML Bottle

Clotrimazole (Topical Solution) USP,1%

Antifungal

Relieves Itching & Burning

  • Greaseless
  • Non-staining

For External use only.
Not for Opthalmic use.

Keep this and all medications out of the reach of children.

CLOTRIMAZOLE 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-8020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
Packaging
#Item CodePackage Description
1NDC:70795-8020-110 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/08/2017
Labeler - GRAXCELL PHARMACEUTICAL, LLC. (056556923)
Registrant - GRAXCELL PHARMACEUTICAL, LLC. (056556923)
Establishment
NameAddressID/FEIOperations
GRAXCELL PHARMACEUTICAL, LLC.056556923relabel(70795-8020)

 
GRAXCELL PHARMACEUTICAL, LLC.

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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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