ANTIFUNGAL TREATMENT LIQUID 25 UNDECLYLENIC ACID- undecylenic acid liquid

Antifungal Treatment Liquid 25 undeclylenic Acid by

Drug Labeling and Warnings

Antifungal Treatment Liquid 25 undeclylenic Acid by is a Otc medication manufactured, distributed, or labeled by Sansar, LLC, Fashion Pearlz, LLP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses

• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
• For effective relief of itching, cracking, burning, redness, soreness, irritation and discomfort

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:

INGREDIENTS AND APPEARANCE

ANTIFUNGAL TREATMENT LIQUID 25 UNDECLYLENIC ACID 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83691-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83691-000-00	1 in 1 BOX	02/01/2023
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	02/01/2023

Labeler - Sansar, LLC (127927811)

Registrant - Fashion Pearlz, LLP (093638579)