CLOTRIMAZOLE- clotrimazole liquid 
Pedifix

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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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.

image description

CLOTRIMAZOLE 
clotrimazole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68927-3491
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)  
EMU OIL (UNII: 344821WD61)  
EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3)  
SOYBEAN OIL (UNII: 241ATL177A)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
ALMOND OIL (UNII: 66YXD4DKO9)  
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
JOJOBA OIL (UNII: 724GKU717M)  
UREA (UNII: 8W8T17847W)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Pure Source969241041manufacture(68927-3491)

Revised: 5/2014
Document Id: c61c85e2-e0b8-47e1-b02e-31a00d11138f
Set id: 55fc471c-e80c-47a0-a148-968e0b3c85ab
Version: 1
Effective Time: 20140507
 
Pedifix