DIABETIC ANTIFUNGAL- undecylenic acid cream 
Lavior Inc

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.

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Active Ingredient

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

Purpose

Antifungal

Uses

Cures most

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

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

Diabetic Antifungal Ointment

DIABETIC ANTIFUNGAL 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71521-391
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71521-391-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/17/2021
Labeler - Lavior Inc (080685327)

Revised: 5/2021
Document Id: c1ed00da-2744-cefc-e053-2a95a90a1ad7
Set id: bdbcf0c0-2cf3-6bd7-e053-2995a90ac3dd
Version: 4
Effective Time: 20210509
 
Lavior Inc