Label: FEMICLEAR YEAST INFECTION TREATMENT- calendula, melaleuca, oleuropein, chamomilla kit
- NDC Code(s): 71042-011-28, 71042-012-14, 71042-013-14
- 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 December 12, 2024
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
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ASK DOCTOR
Ask a doctor before use if you have:
- vaginal itching and discomfort for the first time
- lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition.
- vaginal yeast infections often (such as once a month or three in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
- been exposed to the human immunodeficiency virus (HIV) that causes AIDS
- DO NOT USE
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WHEN USING
When using this product
- do not use tampons, douiches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted infections (STIs)
- do not have vaginal intercourse
- mild increase in vaginal burning, itching, or irritation may occur
- if you do not get complete relief, ask a doctor before using another product
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Adults and children 12 years or over:
Vaginal Ointment: use at bedtime, read enclosed instructions for complete directions.
- to protect clothes, use panty liner
- fill applicator with FemiClear Vaginal Ointment (pink tube).
- lie down in bed. Insert applicator into vagina and inject Femiclear. Remain lying down to avoid leakage.
- discard applicator after use. DO NOT reuse.
- repeat on second night.
Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin outside the vagina (vulva) as needed.
- Children under 12 years: ask a doctor
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STORAGE AND HANDLING
Other information
- do not use if applicator wrapper is torn, open, or incompletely sealed
- do not use if seal over tube opening has been punctured
- do not purchase if carton is open
- Store at 68-77°F (20-25°C). If liquified, refrigerate 10 minutes to thicken.
- this a 2-dose treatment. Most women do not get complete relief of their symptoms in just 2 days. Most women get some improvement in 2 days and complete relief by 7 days.
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FEMICLEAR YEAST INFECTION TREATMENT
calendula, melaleuca, oleuropein, chamomilla kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71042-011 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71042-011-28 1 in 1 CARTON; Type 0: Not a Combination Product 11/12/2021 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
calendula, melaleuca, oleuropein ointmentProduct Information Item Code (Source) NDC:71042-012 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 OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L) OLEUROPEIN 3 [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 OLIVE OIL (UNII: 6UYK2W1W1E) LAVENDER OIL (UNII: ZBP1YXW0H8) YELLOW WAX (UNII: 2ZA36H0S2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71042-012-14 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 11/12/2021 Part 2 of 2 FEMICLEAR EXTERNAL ANTI-ITCH
chamomilla, oleuropein ointmentProduct Information Item Code (Source) NDC:71042-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L) OLEUROPEIN 3 [hp_X] in 14 g MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 3 [hp_X] in 14 g Inactive Ingredients Ingredient Name Strength LAVENDER OIL (UNII: ZBP1YXW0H8) OLIVE OIL (UNII: 6UYK2W1W1E) OATMEAL (UNII: 8PI54V663Y) YELLOW WAX (UNII: 2ZA36H0S2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71042-013-14 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 11/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/12/2021 Labeler - Organicare Nature's Science, LLC (044204745) Establishment Name Address ID/FEI Business Operations Organicare Nature's Science, LLC 044204745 manufacture(71042-011)