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| Product NDC Code | 71042-020 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Femiclear for genital herpes symptoms |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| Labeler Name | Organicare Nature's Science, LLC | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Lemongrass 2X HPUS Olive Extract (Oleuropein) 3X HPUS Willow Bark 3X HPUS
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 12 years of age and older: wash hands before and after applying the ointment apply to affected area t teh first sign of blister, sores, or tingling sensation early use ensures the best results rub in gently and thoroughly use at minimum 4 times daily and then as needed Children under 12 years : ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactve ingredients Beeswax, colloidal oatmeal, essential oil (fragrance), oxygenated olive oil
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Ask your doctor before using this medication for self-treatment, if this is the first time you have genital sores or blisters helps relieve symptoms caused by genital herpes outbreaks helps relieve symptoms: Itching, tingling, burning, and/or pain
Purpose
Information about the drug product’s indications for use.Purpose Antiviral agent Healing agent Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.FemiClear for Genital Herpes Symptoms Lemongrass with Olive extract OATMEAL YELLOW WAX WILLOW BARK WILLOW BARK OLEA EUROPAEA FRUIT VOLATILE OIL OLEUROPEIN OLIVE OIL EAST INDIAN LEMONGRASS OIL EAST INDIAN LEMONGRASS OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.MADE WITH ORGANIC INGREDIENTS FemiClear® FOR GENITAL HERPES SYMPTOMS FAST-ACTING RELIEF FOR RECURRING OUTBREAK SYMPTOMS MULTI-SYMPTOM FAST-ACTING OUTBREAK SYMPTOM RELIEF FROM ITCHING, TINGLING, PAIN, & BURNING HOMEPATHIC MEDICINE NET WT. 0.5OZ(14.2G) FemiClear Multisymptom
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Made and Distributed by Organicare Austin, TX 78744, USA
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you are allergic to any ingredient in this product
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of the reach of children If swallowed, get medical help or contact Poison Control Center right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 512.401.3572 or visit femiclear.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if your symptoms worsen
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product apply only to affected areas Do not use in or near the eyes do not share this product with anyone. This may spread the infection/virus
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a healthcare professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. FemiClear is not a cure for herpes and will not prevent future outbreaks. This product will not stop the spread of herpes viruses or other viruses. Viral infections are contagious. FemiClear does not prevent sexually transmitted infections (STIs). Practice safer sex by using latex or polyurethane condom to reduce risk of getting STIs. FemiClear may damage condoms and diaphragms and cause ethem to fail
Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API