SPL v1
SPL
SPL Set ID 217215c7-f3d8-4acb-e063-6294a90ae3d4
Route
TOPICAL
Published
Effective Date 2024-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogenated Jojoba Oil (4.5 mg) Sunflower Oil (6 mg)
Inactive Ingredients
Allantoin Water Sodium Sulfide Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-06

Description

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,HYDROGENATED JOJOBA OIL,ALLANTOIN,SODIUM SULFIDE

Purpose

Restores damage nail & cuticle


Medication Information

Purpose

Restores damage nail & cuticle

Description

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,HYDROGENATED JOJOBA OIL,ALLANTOIN,SODIUM SULFIDE

Use

1.File the area affected by the nail to enhance the permeability of the essence.2.Clean the surface with a dry swab /cloth.3.Apply the essence to the entire surface of the infected nail.4.Apply the cream twice a day (morning and evening) for at least 4 weeks.

Section 44425-7

Avoid freezing and excessive heat above 40C (104F) )

Store in a cool and dry place.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 51727-6

AQUA

Section 51945-4

Stop Use

Discontinue use if signs of irritation or rash occur.

Warnings

Please keep out of reach of children.Do not swallow.Please clean your hands before use to ensure the best results from the product.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.

Do Not Use

Discontinue use if signs of irritation or rash occur.

Active Ingredient(s)

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,HYDROGENATED JOJOBA OIL,ALLANTOIN,SODIUM SULFIDE


Structured Label Content

Use

1.File the area affected by the nail to enhance the permeability of the essence.2.Clean the surface with a dry swab /cloth.3.Apply the essence to the entire surface of the infected nail.4.Apply the cream twice a day (morning and evening) for at least 4 weeks.

Section 44425-7 (44425-7)

Avoid freezing and excessive heat above 40C (104F) )

Store in a cool and dry place.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 51727-6 (51727-6)

AQUA

Section 51945-4 (51945-4)

Purpose

Restores damage nail & cuticle

Stop Use (STOP USE)

Discontinue use if signs of irritation or rash occur.

Warnings

Please keep out of reach of children.Do not swallow.Please clean your hands before use to ensure the best results from the product.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.

Do Not Use (Do not use)

Discontinue use if signs of irritation or rash occur.

Active Ingredient(s)

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,HYDROGENATED JOJOBA OIL,ALLANTOIN,SODIUM SULFIDE


Advanced Ingredient Data


Raw Label Data

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