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Clotrimazole by Pedifix

Dosage form: liquid
Ingredients: CLOTRIMAZOLE 10mg in 1mL
Labeler: Pedifix
NDC Code: 68927-3491

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 1%

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 doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)
If swallowed, get medical help or contact a poison control center immediately

Active ingredient

Clotrimazole 1%

Inactive ingredients

Aqua, BHT, safflower oil, emu oil, eucalyptus globlus oil, soybean oil, lavender oil, tea tree oil, peppermint oil, olive fruit oil, sweet almond oil, rose hip oil, jojoba oil, vitamin E, urea

Purpose

Anti-fungal

Keep out of reach of children

Directions

Read all package directions and warnings before using:
Use only as directed
Clean the affected area with soap and warm water and dry throughly
Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor
This product is not effective on the scalp or nails
Avoid applying to severly cracked or irritated areas
For athlete's foot pay special attention to spaces between toes, wear well-fitting vetilated 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
Supervise children in the use of this product
Intended foruse by normally healthy adults only
Persons under 18 years of age or thoes with sensitive or allergic skin should use only as directed by a doctor.

Other information

Apply to skin around affected areas. While not allfinger and toe fungal infections are curabel with OTC topical medications. If you see improvement whithin 4 weeks of use, you may continue to use until satisfactory results are obtained.

CLOTRIMAZOLE 
clotrimazole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68927-3491
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CARTHAMUS TINCTORIUS FLOWER OIL 
EMU OIL 
EUCALYPTUS GLOBULUS WHOLE 
SOYBEAN OIL 
LAVENDER OIL 
TEA TREE OIL 
PEPPERMINT OIL 
OLEA EUROPAEA FRUIT VOLATILE OIL 
ALMOND OIL 
ROSA CANINA FLOWER OIL 
JOJOBA OIL 
UREA 
BUTYLATED HYDROXYTOLUENE 
.ALPHA.-TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:68927-3491-115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/05/2014
Labeler - Pedifix (122271935)
Establishment
NameAddressID/FEIOperations
Pure Source969241041manufacture(68927-3491)

Revised: 05/2014
 
Pedifix

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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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