FDA Label for Remedy With Phytoplex

View Indications, Usage & Precautions

Remedy With Phytoplex Product Label

The following document was submitted to the FDA by the labeler of this product Medline Industries, Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


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