Label: FEMICLEAR 2 DAY GENTLE- 2 day yeast infection gentle ointment
- NDC Code(s): 71042-029-14
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Active Ingredients
Active ingredients
Vaginal Ointment
Calendula 6X HPUS ............................................................................................... Healing agent
Melaleuca 6X HPUS........................................................................................... Anti-yeast agent
Olive Extract (Oleuropein) 3X HPUS ............................................Anti-microbial and healing agent
Itch Relief
Chamomilla 3X HPUS ............................................................... Anti-itch and inflammatory agent
Olive Extract (Oleuropein) 3X HPUS ............................................Anti-microbial and healing agent - Warnings
-
Ask a doctor before use if you have:
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 3 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
-
When using this product
When using this product
do not use tampons, douches, 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 - Warnings (Cont.)
- If pregnant or breast-feeding
- Keep out of the reach of children
-
Directions
Directions
Adults and children 12 years or over:
Vaginal Ointment (pink tube): use at bed time, read enclosed instructions for
complete directions.
to protect clothes, use panty liner.
fill applicator with Vaginal Ointment (pink tube) - use 1/2 of the 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 - use other 1/2 of the pink tube
Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin
outside the vagina (vulva) as needed.
Children under 12 years: ask a doctor -
Other information
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° C – 25° C) If liquefied, 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 ingredients
- Questions
- Uses
-
Directions
Directions
Adults and children 12 years or over:
Vaginal Ointment (pink tube): use at bed time, read enclosed instructions for
complete directions.
to protect clothes, use panty liner.
fill applicator with Vaginal Ointment (pink tube) - use 1/2 of the 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 - use other 1/2 of the pink tube
Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin
outside the vagina (vulva) as needed.
Children under 12 years: ask a doctor - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FEMICLEAR 2 DAY GENTLE
2 day yeast infection gentle ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71042-029 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE 0.01 g in 100 g MELALEUCA CAJUPUTI WHOLE (UNII: K62C66D9LN) (MELALEUCA CAJUPUTI WHOLE - UNII:K62C66D9LN) MELALEUCA CAJUPUTI WHOLE 0.01 g in 100 g Inactive Ingredients Ingredient Name Strength OLIVE OIL (UNII: 6UYK2W1W1E) 88 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71042-029-14 1 in 1 CARTON 07/28/2023 1 14.2 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 07/28/2023 Labeler - OrganiCare Nature's Science, LLC (044204745) Establishment Name Address ID/FEI Business Operations OrganiCare Nature's Science, LLC 044204745 manufacture(71042-029)