CLOTRIMAZOIL ANTIFUNGAL- clotrimazole solution 
Pedifix, Inc.

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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ClotrimazOil Antifungal Solution

ClotrimazOil Antifungal Solution


Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses:

For the cure of most:

For relief of:


Warnings:

For external use only

Ask a doctor before use

on children under 12 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 (2weeks for jock itch).

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center immediately.

Inactive Ingredients:

Aqua (Deionized Water), BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycine Soja (Soybean) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Tocopheryl Acetate (Vitamin-E), Urea.

Directions:

Read all package directions and warnings before using.

Other Information

Applyto skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use until satisfactory results are obtained.

Questions? Comments?

Call 1-800-PEDIFIX (733-4349)

ClotrimazOil Antifungal Solution CLOTRIMAZOLE 1%

Exclusive Formula

Kills More Types of Fungus

No Touch, No Mess Brush-on Applicator

Manufactured in the USA for: PediFix, Inc. 301 Fields Lane Brewster, NY 10509 USA

Lot #:

Exp. Date:

Item #3490 REV321 ©2021 PediFix, Inc.

PediFix, ClotrimaZoil and the No Sore Feet Symbol are trademarks of PediFix, Inc.

ClotrimaZoil
Antifungal Treatment

1% CLOTRIMAZOLE

First Clotrimazole & Penetrating Essential Oils Formula

.5 Fl. oz (15 ml)

ClotrimazOil Antifungal Solution .5oz/15ml (68927-3490-1)

Box

CLOTRIMAZOIL ANTIFUNGAL 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68927-3490
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)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
EMU OIL (UNII: 344821WD61)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SOYBEAN OIL (UNII: 241ATL177A)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALMOND OIL (UNII: 66YXD4DKO9)  
JOJOBA OIL (UNII: 724GKU717M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
UREA (UNII: 8W8T17847W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68927-3490-11 in 1 CARTON02/07/2017
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/19/2013
Labeler - Pedifix, Inc. (122271935)
Establishment
NameAddressID/FEIBusiness Operations
PURE SOURCE080354456manufacture(68927-3490)
Establishment
NameAddressID/FEIBusiness Operations
PEDIFIX, INC.122271935label(68927-3490)

Revised: 4/2021
Document Id: c0a7230b-949a-2f80-e053-2a95a90a4c89
Set id: fd79346a-fba3-49ec-9cd3-5c00bedb4acb
Version: 4
Effective Time: 20210423
 
Pedifix, Inc.