Remedy with Phytoplex Antifungal Clear

Dosage form: ointment
Ingredients: MICONAZOLE NITRATE 2g in 100g
Labeler: Medline Industries Inc.
NDC Code: 53329-167

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.

Drug Facts

Active ingredient

Miconazole Nitrate 2.0%

Purpose

Antifungal

Uses
For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
For the treatment of superficial skin infections caused by yeast (Candida albicans)
Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch.

Warnings

For External Use Only.

Do not use
on children under 2 years of age unless directed by a doctor
on scalp or nails

When using this product
avoid contact with the eyes

Stop use and ask a doctor if
irritation occurs
there is no improvement within 4 weeks for athlete's foot and ringworm
there is no improvement within 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
Clean the affected area and dry thoroughly
Apply a layer of Cream 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, 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
If condition persists longer, consult a doctor
This product is not effective on the scalp or nails.

Other information
Protect from freezing. Avoid excessive heat.

Inactive ingredients

Aphanizomemnon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Extract, Carboxymethyl Cellulose, Carthamus Tinctorius (Safflower) Seed Oil, Dimethicone, Eugenia Caryophyllus (Clove) Flower Extract, Glycine Soja (Soybean) Oil, Olea Europaea Fruit (Olive) Oil, Petrolatum, Zea Mays (Corn) Oil

Package/Label Principal Display Panel

MEDLINE

NDC 53329-167-10

REMEDY®

PHYTOPLEX™

Botanical Nutrition for Sensitive Skin

ANTIFUNGAL

CLEAR

Helsp treat and relieve itching

And burning associated

With a fungal infection

Miconazole Nitrate 2%

OINTMENT

Paraben Free

Hypoallergenic

Net Wt 2.5 oz (71 g)

REMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR 
miconazole nitrate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-167
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GREEN TEA LEAF 
CARBOXYMETHYLCELLULOSE 
SAFFLOWER OIL 
DIMETHICONE 
CLOVE 
SOYBEAN OIL 
OLIVE OIL 
PETROLATUM 
CORN OIL 
Packaging
#Item CodePackage Description
1NDC:53329-167-1071 g in 1 TUBE
2NDC:53329-167-96144 PACKET in 1 BOX
2NDC:53329-167-165 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/01/2011
Labeler - Medline Industries Inc. (025460908)

Revised: 04/2012
 
Medline Industries Inc.

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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