ANTIFUNGAL TREATMENT LIQUID 25 UNDECLYLENIC ACID- undecylenic acid liquid 
Sansar, LLC

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Antifungal Treatment Liquid 25 undeclylenic Acid

Drug Facts

Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses

Warnings

For external use only.

Do not use 

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

When using this product

  • avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs or if there is no improvement within 4 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean 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 athlete's 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.

Inactive ingredients

Aloe Vera Extract, Canola Oil, Clove Bud Oil, Lavender Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond Oil, Tea Tree Oil, Tocopheryl Acetate

Package Labeling:

Outer Package0Inner Package0

ANTIFUNGAL TREATMENT LIQUID 25 UNDECLYLENIC ACID 
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83691-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CANOLA OIL (UNII: 331KBJ17RK)  
CLOVE OIL (UNII: 578389D6D0)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
JOJOBA OIL (UNII: 724GKU717M)  
MANUKA OIL (UNII: M6QU9ZUH2X)  
OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
ALMOND OIL (UNII: 66YXD4DKO9)  
TEA TREE OIL (UNII: VIF565UC2G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83691-000-001 in 1 BOX02/01/2023
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00502/01/2023
Labeler - Sansar, LLC (127927811)
Registrant - Fashion Pearlz, LLP (093638579)

Revised: 11/2023
Document Id: 0a98e57c-f850-f8a4-e063-6294a90a063d
Set id: 2ae0f300-154e-44c8-bcc3-b5c334e661ac
Version: 2
Effective Time: 20231120
 
Sansar, LLC