Label: TOENAIL FUNGUS / NAIL REPAIR PEN- tea tree oil solution
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Contains inactivated NDC Code(s)
NDC Code(s): 82743-101-01, 82743-101-03, 82743-101-30, 82743-101-63 - Packager: VITAL SYNERGY LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated May 20, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOENAIL FUNGUS / NAIL REPAIR PEN
tea tree oil solutionProduct 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)