NDC 71042-010 Femiclear Vaginal Itch Relief

Chamomilla, Olive Extract

NDC Product Code 71042-010

NDC 71042-010-14

Package Description: 1 TUBE in 1 CARTON > 14.2 g in 1 TUBE

NDC Product Information

Femiclear Vaginal Itch Relief with NDC 71042-010 is a a human over the counter drug product labeled by Organicare Nature's Science, Llc. The generic name of Femiclear Vaginal Itch Relief is chamomilla, olive extract. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Organicare Nature's Science, Llc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Femiclear Vaginal Itch Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CHAMOMILE 3 [hp_X]/14g
  • OLEA EUROPAEA FRUIT VOLATILE OIL 2 [hp_X]/14g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • OATMEAL (UNII: 8PI54V663Y)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • YELLOW WAX (UNII: 2ZA36H0S2V)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Organicare Nature's Science, Llc
Labeler Code: 71042
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-20-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Femiclear Vaginal Itch Relief Product Label Images

Femiclear Vaginal Itch Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.Made and Distributed byOrganicareAustin, TX 78744, USA

Otc - Active Ingredient

Active ingredientsChamomilla 3X HPUSOlive Extract 2X HPUS

Otc - Purpose

PurposeAnti-itch and anti-inflammatory agentAntimicrobial and healing agent

Indications & Usage

UseTemporarily relieves external feminine itching

Warnings

WarningsFor external use.FemiClear may damage condoms and diaphragms and cause them to fail.

Otc - Do Not Use

  • Do not useif you have a vaginal discharge. Consult a doctor.if you are allergic to any of the ingredients

Otc - When Using

  • When using this productavoid contact with the eyes

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few daysrash or other allergic reaction develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

DirectionsAdults and children 12 years of age and olderApply a fingertip amount to affected area as needed.children under 12 yearsconsult a doctor

Inactive Ingredient

Inactive ingredientsBeeswax, colloidal oatmeal, essential oil (fragrance), oxygenated olive oil

Otc - Questions

Questions? Call
512.401.3572 or visit
femiclear.com

* Please review the disclaimer below.