DIABETIC ANTIFUNGAL- undecylenic acid cream

Diabetic Antifungal by

Drug Labeling and Warnings

Diabetic Antifungal by is a Otc medication manufactured, distributed, or labeled by Lavior Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Undecylenic Acid 10%...................Antifungal

Purpose

Antifungal

Uses

Cures most

• athlete's foot (tinea pedis)
• jock itch (tinea cruris)
• ringworm (tinea corporis)

Relieves itching, burning, cracking, and scaling.

Warnings

For external use only. Avoid contact with eyes.

Do not use

on children under 2 years of age unless directed by a doctor

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

• read all warnings and directions
• use only as directed
• 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 at room temperature

Inactive ingredients

Water/Aqua/Eau, Propanediol, Inula Viscosa Flower/Leaf/Stem Extract, Urea, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Arachidyl Alcohol, Zea Mays (Corn) Starch, Behenyl Alcohol, Dimethicone, Pentaerythrityl Tetraethylhexanoate, Synthetic Beeswax, Glycerin, Phenoxyethanol, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire de Candelilla, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire de Carnauba, Arachidyl Glucoside, Glyceryl Stearate SE, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, ButyrospermumParkii (Shea) Butter, Ethylhexylglycerin, Disodium EDTA, Xanthan Gum, Hydroxypropyl Bispalmitamide MEA, Polyglyceryl-2 Stearate, Glyceryl Stearate, Palmitic Acid, Stearyl Alcohol, Pentylene Glycol, Isomerized Safflower Acid, Caprylyl Glycol

Questions?

Call toll free 1-844-474-2552 or visit www.lavior.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIABETIC ANTIFUNGAL 
undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71521-391
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PROPANEDIOL (UNII: 5965N8W85T)
PALMITIC ACID (UNII: 2V16EO95H1)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
STARCH, CORN (UNII: O8232NY3SJ)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
UREA (UNII: 8W8T17847W)
CANDELILLA WAX (UNII: WL0328HX19)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE (UNII: 92RU3N3Y1O)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)
SHEA BUTTER (UNII: K49155WL9Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TEA TREE OIL (UNII: VIF565UC2G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)
ISOMERIZED SAFFLOWER ACID (UNII: 70S2158RCI)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71521-391-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/17/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/17/2021

Labeler - Lavior Inc (080685327)