TOENAIL FUNGUS / NAIL REPAIR PEN- tea tree oil solution

TOENAIL FUNGUS / NAIL REPAIR PEN by

Drug Labeling and Warnings

TOENAIL FUNGUS / NAIL REPAIR PEN by is a Homeopathic medication manufactured, distributed, or labeled by VITAL SYNERGY LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

TEA TREE OIL 10X HPUS

PURPOSE

ANTIFUNGAL

USES

STRONG NAILS FAST

YELLOW BROKEN BRITTLE TOENAILS & FINGERNAILS

WARNINGS

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF ADVERSE SKIN REACTION OCCURS. CONSULT YOUR HEALTH CARE PHYSICIAN IF PREGNANT, NURSING, OR FOR A CHILD UNDER THE AGE OF TWO.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

TEST ON A SMALL PART OF A NAIL FIRST. APPLY TOPICALLY TWICE PER DAY ON THE AFFECTED AREA.

INACTIVE INGREDIENTS

ALOE VERA EXTRACT, EUCALYPTUS OIL, LAVENDER OIL, SWEET ALMOND OIL, VITAMIN C, AND VITAMIN E

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOENAIL FUNGUS / NAIL REPAIR PEN 
tea tree oil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82743-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	10 [hp_X]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82743-101-30	1 in 1 BOX	05/16/2022
1	NDC: 82743-101-01	30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 82743-101-63	6 in 1 BOX	05/16/2022
2	NDC: 82743-101-03	3 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/16/2022

Labeler - VITAL SYNERGY LLC (082975816)