067 Remedy with Phytoplex Antifungal Ointment

Remedy with Phytoplex Antifungal Clear by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-167
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-167-1071 g in 1 TUBE; Type 0: Not a Combination Product08/01/201112/31/2018
2NDC: 53329-167-96144 in 1 BOX08/01/201112/31/2018
2NDC: 53329-167-165 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/01/201112/31/2018
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.