83804-006 Sefudun Fungal Nail Patches

83804-006 Sefudun Fungal Nail Patches
SPL v1
SPL
SPL Set ID 38db97d6-27c8-da99-e063-6294a90aac66
Route
TOPICAL
Published
Effective Date 2025-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.01 g)
Inactive Ingredients
Dimethicone, Unspecified Polyester (adipic Acid, 1,6-hexanediol, Neopentyl Glycol)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Glycerin 1%


Medication Information

Warnings and Precautions

For extemal use only.

Indications and Usage

REDUCES DISCOLOR-ATION & THICKNESS, REVITALIZESBRITTLE NAILS,IMPROVES NAILAPPEARANCE

Dosage and Administration

Clean and dry the affecled area before application. Remove the prolective filmand peel off the release paper from the patch. Place the sticky side of the patchdirectiy onto the infected area of the nail. Gently fold the sides of the paich arotndyour toe or finger for secure adherence. Leave the patch on for 6.8 hours, ideallyovernight, to allow for effective treatment.

Description

Glycerin 1%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9

Discontinue use if an allergic reaction occurs.

Section 50567-7

Avoid contact with eyes, mouth, mucous membranes and wounds.

Section 50570-1

Not recommended whilepregnant or breastfeeding.

Section 51727-6

Polyester, Silicone Oil

Section 51945-4

Section 55105-1

antifungal

Section 55106-9

Glycerin 1%


Structured Label Content

Indications and Usage (34067-9)

REDUCES DISCOLOR-ATION & THICKNESS, REVITALIZESBRITTLE NAILS,IMPROVES NAILAPPEARANCE

Dosage and Administration (34068-7)

Clean and dry the affecled area before application. Remove the prolective filmand peel off the release paper from the patch. Place the sticky side of the patchdirectiy onto the infected area of the nail. Gently fold the sides of the paich arotndyour toe or finger for secure adherence. Leave the patch on for 6.8 hours, ideallyovernight, to allow for effective treatment.

Warnings and Precautions (34071-1)

For extemal use only.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9 (50566-9)

Discontinue use if an allergic reaction occurs.

Section 50567-7 (50567-7)

Avoid contact with eyes, mouth, mucous membranes and wounds.

Section 50570-1 (50570-1)

Not recommended whilepregnant or breastfeeding.

Section 51727-6 (51727-6)

Polyester, Silicone Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

antifungal

Section 55106-9 (55106-9)

Glycerin 1%


Advanced Ingredient Data


Raw Label Data

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