Label: FEMICLEAR YEAST INFECTION TREATMENT- olive extract, calendula, melaleuca kit
- NDC Code(s): 71042-007-28, 71042-008-14, 71042-009-14
- Packager: Organicare Nature's Science, 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 November 8, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
ASK DOCTOR
Ask a doctor before use if you
- Have 1 or more of the following: abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge
- Get vaginal yeast infections often (such as once a month or three in 6 months)
- May have been exposed to the human immunodeficiency virus (HIV) that causes AIDS
- Are under 12 years of age.
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- Before use at bedtime, read enclosed instructions for complete directions.
- Adults and children 12 years and older:
- Refrigerate Vaginal Ointment for 20 minutes immediately before use.
- To protect clothes, use panty liner.
- Fill applicator with FemiClear Vaginal Ointment as shown.
- Lie down in bed. Insert applicator into vagina and inject Femiclear. Remain lying down to avoid leakage. Repeat on second night. Discard applicator after each use.
- External Itch Ointment: Squeeze a small amount of ointment onto your fingertip. Apply the ointment onto the itchy, irritated skin outside the vagina. Use as needed.
- Children under 12 years old: ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FEMICLEAR YEAST INFECTION TREATMENT
olive extract, calendula, melaleuca kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71042-007 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71042-007-28 1 in 1 CARTON; Type 0: Not a Combination Product 12/20/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 14 g Part 2 1 TUBE 14 g Part 1 of 2 FEMICLEAR VAGINAL
olive extract, calendula, melaleuca ointmentProduct Information Item Code (Source) NDC:71042-008 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 14 g OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEA EUROPAEA FRUIT VOLATILE OIL - UNII:8E7358CX1J) OLEA EUROPAEA FRUIT VOLATILE OIL 2 [hp_X] in 14 g MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) (MELALEUCA CAJUPUTI LEAF OIL - UNII:5O59RMR6DU) MELALEUCA CAJUPUTI LEAF OIL 3 [hp_X] in 14 g Inactive Ingredients Ingredient Name Strength LAVENDER OIL (UNII: ZBP1YXW0H8) OLIVE OIL (UNII: 6UYK2W1W1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71042-008-14 14 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/20/2017 Part 2 of 2 FEMICLEAR EXTERNAL ANTI-ITCH
olive extract, calendula, melaleuca ointmentProduct Information Item Code (Source) NDC:71042-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEA EUROPAEA FRUIT VOLATILE OIL - UNII:8E7358CX1J) OLEA EUROPAEA FRUIT VOLATILE OIL 2 [hp_X] in 14 g MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) (MELALEUCA CAJUPUTI LEAF OIL - UNII:5O59RMR6DU) MELALEUCA CAJUPUTI LEAF OIL 3 [hp_X] in 14 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 14 g Inactive Ingredients Ingredient Name Strength LAVENDER OIL (UNII: ZBP1YXW0H8) OLIVE OIL (UNII: 6UYK2W1W1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71042-009-14 14 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/20/2017 Labeler - Organicare Nature's Science, LLC (044204745)
