85214-025-05

Drug Facts

Composition & Product

Active Ingredients

Undecylenic Acid (25 g)

Inactive Ingredients

Dmdm Hydantoin Water Isopropyl Alcohol .alpha.-tocopherol Acetate Melaleuca Alternifolia Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-06

Medication Information

Warnings and Precautions

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water

Description

Undecylenic Acid 25%

Uses:

Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis).

Relieves itching, scaling, cracking, burning, and redness.

Section 50565-1

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

Section 51727-6

Isopropyl Alcohol, Water (Aqua), Tocopheryl Acetate, DMDM Hydantoin, Melaleuca Alternifolia Leaf Oil.

Section 55105-1

Antifungal

Section 55106-9

Undecylenic Acid 25%

Directions:

Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily 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. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Other Information:

Store at room temperature 15° - 30°C (59° - 86°F)

Extremely Flammable:

Keep away from fire or flame.

Stop Use and Ask A Doctor If

Irritation occurs or if there is no improvement within 4 weeks.

South Beach Multi Purpose Nail Repair

Structured Label Content

Uses: (USES:)

Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis).

Relieves itching, scaling, cracking, burning, and redness.

Warnings and Precautions (34071-1)

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Isopropyl Alcohol, Water (Aqua), Tocopheryl Acetate, DMDM Hydantoin, Melaleuca Alternifolia Leaf Oil.

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Undecylenic Acid 25%

Directions: (DIRECTIONS:)

Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily 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. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Other Information: (OTHER INFORMATION:)

Store at room temperature 15° - 30°C (59° - 86°F)

Extremely Flammable: (EXTREMELY FLAMMABLE:)

Keep away from fire or flame.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

Irritation occurs or if there is no improvement within 4 weeks.

South Beach Multi Purpose Nail Repair (SOUTH BEACH MULTI-PURPOSE NAIL REPAIR)

Advanced Ingredient Data

[{"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "UNDECYLENIC ACID", "unii": "K3D86KJ24N", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MELALEUCA ALTERNIFOLIA LEAF", "unii": "G43C57162K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES:": "Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis). Relieves itching, scaling, cracking, burning, and redness.", "34071-1": "For external use only. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water", "50565-1": "If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Isopropyl Alcohol, Water (Aqua), Tocopheryl Acetate, DMDM Hydantoin, Melaleuca Alternifolia Leaf Oil.", "55105-1": "Antifungal", "55106-9": "Undecylenic Acid 25%", "DIRECTIONS:": "Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily 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. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.", "OTHER INFORMATION:": "Store at room temperature 15° - 30°C (59° - 86°F)", "EXTREMELY FLAMMABLE:": "Keep away from fire or flame.", "STOP USE AND ASK A DOCTOR IF": "Irritation occurs or if there is no improvement within 4 weeks."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information