CLOTRIMAZOIL ANTIFUNGAL- clotrimazole solution

ClotrimazOil Antifungal by

Drug Labeling and Warnings

ClotrimazOil Antifungal by is a Otc medication manufactured, distributed, or labeled by Pedifix, Inc., PURE SOURCE, PEDIFIX, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ClotrimazOil Antifungal Solution

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses:

For the cure of most:

• athlete’s foot (tinea pedis)
• ringworm (tinea corporis)
• jock itch (tinea cruris)

For relief of:

• itching
• scaling
• cracking
• burning
• redness
• soreness
• irritation
• discomforts which may 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 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.

• Use only as directed.
• Clean the affected area with soap and warm water and dry thoroughly.
• Apply a thin layer of CLORTIMAZOIL 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 severely cracked or irritated areas.
• For athlete’s foot: pay special attention to spaces between 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.
• Supervise children in the use of this product.
• Supervise children in the use of this product.
• Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.

Other Information

Apply CLOTRIMAZOIL to 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 CLOTRIMAZOIL until satisfactory results are obtained.

• You may report serious side effects to the phone number provided under Questions? Comments? on side panel.

Questions? Comments?

Call 1-800-PEDIFIX (733-4349)
Monday–Friday, 9:00 AM to 5:00 PM Eastern Time

ClotrimazOil Antifungal Solution CLOTRIMAZOLE 1%

DOCTOR RECOMMENDED

Broad Spectrum Antifungal Kills 6 Types of Fungus

Highly effective on infected surfaces, wherever reachable with the brush-on applicator.

Manufactured in the USA for: PediFix, Inc. 281 Fields Lane Brewster, NY 10509 USA

Lot #:

Exp. Date:

Item #3490 REV513 ©2013 PediFix, Inc.

PediFix and ClotrimazOil are trademarks of PediFix, Inc.

PRINCIPAL DISPLAY PANEL

NEW clotrimazOil TM

Antifungal Solution  CLOTRIMAZOLE 1%

Penetrating Carrier Oils Formula

Dispensed Only by Physicians

PediFix

.5 Fl. oz (15 ml)

ClotrimazOil Antifungal Solution .5oz/15ml (

68927-3490-1)

INGREDIENTS AND APPEARANCE

CLOTRIMAZOIL ANTIFUNGAL 
clotrimazole solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68927-3490
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68927-3490-1	1 in 1 CARTON	02/07/2017
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/19/2013

Labeler - Pedifix, Inc. (122271935)