DiabetiDerm Antifungal description, usages, side effects, indications, overdosage, supplying and lots more!

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DiabetiDerm Antifungal

Health Care Products
Hi-Tech Pharmacal Co., Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Undecylenic Acid 10%

Purpose

Antifungal

DiabetiDerm Antifungal Uses

  • cures most athlete's foot
  • cures most jock itch and ringworm
  • relieves itching, burning, cracking, and scaling which accompany these conditions

Warnings

For external use only.

Do not use

  • on children under 2 years of age unless directed by a doctor
  • for vaginal yeast infections

When using this product

do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and consult a doctor if

irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or 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

  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.

    Supervise children in the use of this product.

  • for athletes 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
  • wash hands after each use

DiabetiDerm Antifungal Other information

  • store between 2° and 30°C (36° and 86°F).

Inactive ingredients

Aloe Vera, Arginine, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearate, Lavender Oil, Methylparaben, Ornithine HCl, PEG-100 Stearate, Propylparaben, Sodium Polyacrylate, Sorbitan Stearate, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water.

Questions or comments?

Call: 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

Rev. 481:03 4/12

Package/Label Principal Display Panel

DiabetiDerm Antifungal

 PODIATRIST RECOMMENDED

DiabetiDerm® Antifungal Cream

contains Undecylenic Acid 10% and

L-Arginine HCl

KILLS TOENAIL & FOOT FUNGUS

  • Plus Tea Tree Oil and Soothing Aloe Vera

NET WT 1.5 OZ (42 g)

DiabetiDerm Antifungal

undecylenic acid CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61787-481
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
UNDECYLENIC ACID 0.1 g

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
ARGININE
CETYL ALCOHOL
Clotrimazole
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
LAVANDULA ANGUSTIFOLIA FLOWER
MELALEUCA ALTERNIFOLIA LEAF
METHYLPARABEN
Eflornithine Hydrochloride
PEG-100 STEARATE
PROPYLPARABEN
SORBITAN MONOSTEARATE
STEARIC ACID
TROLAMINE
UREA
water
SODIUM POLYACRYLATE (2500000 MW)

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 42 in 1 TUBE
2 NDC:61787-481-15 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2007-07-01


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