70947-025-15

70947-025-15
SPL v5
SPL
SPL Set ID 3cf281eb-616e-4a17-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2023-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g)
Inactive Ingredients
Dmdm Hydantoin .alpha.-tocopherol Acetate, D- Isopropyl Alcohol Melaleuca Alternifolia Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-01

Description

Undecylenic Acid 25%


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 50566-9

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

Section 51727-6

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

Section 55105-1

Antifungal

Section 55106-9

Undecylenic Acid 25%

Directions:

Shake well before using. 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.

Questions Or Comments?

Contact us +1-305-468-8270

Eternal Spirit Beauty Fungi Fresh


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 50566-9 (50566-9)

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

Section 51727-6 (51727-6)

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

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Undecylenic Acid 25%

Directions: (DIRECTIONS:)

Shake well before using. 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.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Contact us +1-305-468-8270

Eternal Spirit Beauty Fungi Fresh (ETERNAL SPIRIT BEAUTY FUNGI FRESH)


Advanced Ingredient Data


Raw Label Data

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