KAKALSA TOENAIL FUNGUS TREATMENT- undecylenic acid 25% toenail fungus treatment liquid

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Use

Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning, redness, soreness, and irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

Warnings

For external use only.

Do not use

·On children under 2 years of age unless directed by a doctor.
·If you're pregnant, breastfeeding, or any allergic reaction occurs.

When Using

·Avoid contact with eyes.
·If contact occurs, immediately rinse thoroughly with water or seek medical advice if necessary.

Stop Use

·Irritation occurs.
·No improvement if you have persisted in using it for 4 weeks.

Ask Doctor

·Irritation occurs.
·No improvement if you have persisted in using it for 4 weeks.

Keep Out Of Reach Of Children

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

Directions

For athlete's foot and ringworm:
use daily for 4 weeks. 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. This product is not effective for the treatment of ring worm of the scalp or nails.
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. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.

Other information

Store at 15°–30° (59°–86°F) and out of direct sunlight.

Inactive ingredients

Purified Water, Aloe Vera Extract, Tea Tree Oil, Clove Bud Oil, Lavender Oil, Jojoba Oil, Manuka Oil, Peppermint Oil, Oregano Leaf Oil, Propolis, Almond Oil, Alpha-Tocopherol, Acetate (Vitamin E).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KAKALSA TOENAIL FUNGUS TREATMENT 
undecylenic acid 25% toenail fungus treatment liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85248-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MANUKA OIL (UNII: M6QU9ZUH2X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
TEA TREE OIL (UNII: VIF565UC2G)
ALMOND OIL (UNII: 66YXD4DKO9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85248-204-01	4 in 1 BOX	05/06/2026
1		3 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 85248-204-02	56 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/06/2026

Labeler - Jiangxi Yudexi Pharmaceutical Co., LTD (455662836)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.		411295811	manufacture(85248-204)