REMEDY WITH PHYTOPLEX- miconazole nitrate ointment

Remedy with Phytoplex by

Drug Labeling and Warnings

Remedy with Phytoplex by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ointment 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

7-dehydrocholestrol, aphanizomenon flos-aquae (algae) extract, camellia sinensis (green tea) extract, caprylic/capric triglycerides, carboxymethyl cellulose, carthamus tinctorius (safflower) seed oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, olea europaea fruit (olive) oil, petrolatum, phospholipids, tocopherol acetate, water, yeast ferment extract, zea mays (corn) oil

Package/Label Principal Display Panel

NDC: 53329-171-10

MEDLINE

REMEDY®

PHYTOPLEX®

Botanical Nutrition for Sensitive Skin

Treatment

Antifungal Ointment

Miconazole Nitrate 2%

Helps treat and relieve itching

& burning associated with a fungal infection

CHG Compatible

Paraben Free

Hypoallergenic

Net Wt 2.5 oz (71 g)

INGREDIENTS AND APPEARANCE

REMEDY WITH PHYTOPLEX 
miconazole nitrate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-171
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIMETHICONE (UNII: 92RU3N3Y1O)
CLOVE (UNII: K48IKT5321)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
OLIVE OIL (UNII: 6UYK2W1W1E)
PETROLATUM (UNII: 4T6H12BN9U)
CORN OIL (UNII: 8470G57WFM)
APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
YEAST (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-171-10	71 g in 1 TUBE; Type 0: Not a Combination Product	04/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/11/2016

Labeler - Medline Industries Inc. (025460908)