NAIL LAB FUNGOMER NAILELIXIR- tolnaftate 1% oil

NAIL LAB FUNGOMER NAILELIXIR by

Drug Labeling and Warnings

NAIL LAB FUNGOMER NAILELIXIR by is a Otc medication manufactured, distributed, or labeled by Foshan Miwei Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Tolnaftate 1%

PURPOSE

Purpose

Antifungal

INDICATIONS & USAGE

Uses

• For all caused by nail fungus
• Nail discoloration
• Nail thickening
• Nail splitting
• Nail crumbling

WARNINGS

Warnings

• External Use Only.
• Avoid contact with eyes and mouth.
• If contact occurs, rinse immediately.
• Test on a small skin area 24 hours before full use.
• Discontinue if irritation occurs. Keep out of reach of children.
• If pregnant or nursing, seek medical advice before use.
• Avoid mixing with other products.
• Check the expiry date.
• Do not apply to broken or inflamed skin.

DO NOT USE

Do not apply to broken or inflamed skin.

WHEN USING

• Avoid contact with eyes and mouth.
• If contact occurs, rinse immediately.
• Test on a small skin area 24 hours before full use.

STOP USE

Discontinue if irritation occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

If pregnant or nursing, seek medical advice before use.

DOSAGE & ADMINISTRATION

Directions:

• Soak your nails in warm water for 10-15 minutes.
• Gently dry the needed area using a clean paper towel.
• Use the nail file to remove the soft part of the nail.
• Apply a few drops of oil on the needed area using the pipette.
• Spread the liquid over the cuticles and nearby skin using the brush.
• Gently massage the solution into the needed area.
• Allow the solution to absorb for 10-1 5 minutes. Avoid contact with eyes and mouth.
• Repeat 3 times a day. Recommended to leave on overnight.
• Travel Pen: Rotate the top clockwise to dispense the solution. Designed for your convenience, making every trip easier.

STORAGE AND HANDLING

Store in a cool, dry place, away from direct sunlight.

OTHER SAFETY INFORMATION

Other information:

• Store in a cool, dry place, away from direct sunlight.
• Ensure nail enhancement equipment is sterilized prior to each application.
• Utilize only uncontaminated and sanitized supplies.
• Maintain nails by keeping them neatly trimmed and devoid of any accumulated debris.
• Should any concerns arise, seek professional medical consultation. promptly.

INACTIVE INGREDIENT

Inactive Ingredients:

Vitis Vinifera Seed Oil, Simmondsia Chinensis Seed Oil, Prunus Amygdalus Dulcis Oil, Argania Spinosa Kernel Oil, Melaleuca Alternifolia Leaf Oil, Tocopheryl Acetate, Origanum Vulgare Oil, Limonene, Linalool

QUESTIONS

Questions?

Email: support @ nail-lab.co

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAIL LAB FUNGOMER NAILELIXIR 
tolnaftate 1% oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84222-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LINALOOL (UNII: D81QY6I88E)	0.0015 mL  in 100 mL
ARGAN OIL (UNII: 4V59G5UW9X)	5 mL  in 100 mL
TEA TREE OIL (UNII: VIF565UC2G)	2.85 mL  in 100 mL
GRAPE SEED OIL (UNII: 930MLC8XGG)	49.95 mL  in 100 mL
JOJOBA OIL (UNII: 724GKU717M)	20 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	1 mL  in 100 mL
ALMOND OIL (UNII: 66YXD4DKO9)	20 mL  in 100 mL
OREGANO LEAF OIL (UNII: 7D0CGR40U1)	1 mL  in 100 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.15 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84222-002-01	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	08/28/2024
2	NDC: 84222-002-02	3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	08/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/28/2024

Labeler - Foshan Miwei Cosmetics Co., Ltd. (554530932)