Label: DIABETIDERM ANTIFUNGAL- undecylenic acid cream
- NDC Code(s): 61787-481-15
- Packager: Health Care Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient
Undecylenic Acid 10%Close
- cures most athlete's foot
- cures most jock itch and ringworm
- relieves itching, burning, cracking, and scaling which accompany these conditions
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.
- 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
- 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.Close
- 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 4/12Close
- Package/Label Principal Display Panel
DiabetiDerm® Antifungal Cream
contains Undecylenic Acid 10% and
KILLS TOENAIL & FOOT FUNGUS
- Plus Tea Tree Oil and Soothing Aloe Vera
NET WT 1.5 OZ (42 g)Close
- INGREDIENTS AND APPEARANCE
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 (UNDECYLENIC ACID) UNDECYLENIC ACID 0.1 g in 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 Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61787-481-15 1 in 1 CARTON 1 42 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/01/2007 12/31/2014 Labeler - Health Care Products (101196749) Registrant - Hi-Tech Pharmacal Co., Inc. (101196749) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging, LLC 809172885 MANUFACTURE(61787-481)