Label: DIABETIC ANTIFUNGAL- undecylenic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71521-391-50 - Packager: Lavior Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 9, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and consult a doctor if
- Keep out of reach of children.
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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
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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?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIABETIC ANTIFUNGAL
undecylenic acid creamProduct 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)
