REMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR- miconazole nitrate ointment
Medline Industries 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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067 Remedy with Phytoplex Antifungal Ointment

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

NDC 53329-167-10

MEDLINE

REMEDY®

PHYTOPLEX®

Botanical Nutrition for Sensitive Skin

Treatment

Antifungal Ointment

Miconazole Nitrate 2%

Helps treat and relieve itching

& burning with a fungal infection

CHG Compatible

Paraben Free

Hypoallergenic

Net Wt 2.5 oz (71 g)

label

REMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR
miconazole nitrate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-167
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIMETHICONE (UNII: 92RU3N3Y1O)
CLOVE (UNII: K48IKT5321)
SOYBEAN OIL (UNII: 241ATL177A)
OLIVE OIL (UNII: 6UYK2W1W1E)
PETROLATUM (UNII: 4T6H12BN9U)
CORN OIL (UNII: 8470G57WFM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-167-10	71 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2011	12/31/2018
2	NDC:53329-167-96	144 in 1 BOX	08/01/2011	12/31/2018
2	NDC:53329-167-16	5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	08/01/2011	12/31/2018

Labeler - Medline Industries Inc. (025460908)

Revised: 3/2020

Document Id: 9ff9c935-84cc-0610-e053-2995a90a7fab

Set id: ce16b0c5-a0de-423e-a8f5-3d75d85dd322

Version: 8

Effective Time: 20200303

Medline Industries Inc.