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Femiclear infection protection - Medication Information

Product NDC Code 71042-028
Drug Name

Femiclear infection protection

Type Brand
Active Ingredients
Melaleuca cajuputi whole .01 g/g
Thymol .01 g/g
Route TOPICAL
Dosage Form CREAM
Labeler Name OrganiCare Nature's Science, LLC
Packages
Package NDC Code Description
71042-028-14 1 tube in 1 carton (71042-028-14) / 14.2 g in 1 tube
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Melaleuca 6X HPUS ................................................... Anti-yeast agent Olive Extract (Oleuropein) 5X HPUS..... Anti-microbial and healing agent Thymol 6X HPUS .................................................. Anti-bacterial agent

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 or over:  Wash hands before and after use.  Squeeze desired amount into applicator.  Insert applicator into vagina and inject cream.  Clean applicator after use and reuse.  Children under 12 years: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Water, Oxygenated Olive Oil, essential oil (natural fragrance), Cetearyl Olivate, Sorbitan Olivate, Xanthan Gum, Cetyl Esters, Phenethyl Alcohol, Pentylene Glycol, Hyaluronic Acid

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.
This product is intended to help prevent bacterial vaginosis (BV) and yeast infections, and to moisturize.

Purpose

Information about the drug product’s indications for use.
This product is intended to help prevent bacterial vaginosis (BV) and yeast infections, and to moisturize.

Spl product data elements

Usually a list of ingredients in a drug product.
FemiClear Infection Protection Vaginal Cream PENTYLENE GLYCOL XANTHAN GUM MELALEUCA CAJUPUTI WHOLE MELALEUCA CAJUPUTI WHOLE HYALURONIC ACID (NON-ANIMAL STABILIZED) CETYL ESTERS WAX THYMOL THYMOL WATER

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.
FemiClear Vulva Cream

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
 rash or allergic reaction develops  vaginal symptoms develop  you get a rash or hives, abdominal pain, fever, chills, nausea or vomiting

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.
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 a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
 do not use if applicator wrapper is torn, open or incompletely sealed  do not use if seal over tube opening has been punctured  Store at 68° – 77° F (20° C – 25° C)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
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.
 rash or allergic reaction develops  vaginal symptoms develop  you get a rash or hives, abdominal pain, fever, chills, nausea or vomiting

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.
 can be used in combination with other medications, please consult a healthcare professional  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).

Pregnancy or breast feeding

Pregnancy 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.
For vaginal use only. FemiClear may damage condoms and diaphragms and cause them to fail. FemiClear does not prevent sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs. FemiClear does not eliminate the risk of infections.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me 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