NDC 82018-0010 Estriol 5.0 Cream

Estriol

NDC Product Code 82018-0010

NDC 82018-0010-4

Package Description: 85 g in 1 BOTTLE, PUMP

NDC Product Information

Estriol 5.0 Cream with NDC 82018-0010 is a a human over the counter drug product labeled by Shyne Brands. The generic name of Estriol 5.0 Cream is estriol. The product's dosage form is cream and is administered via transdermal form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Estriol 5.0 Cream 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.


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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALLANTOIN (UNII: 344S277G0Z)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

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

  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Product Labeler Information

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

Labeler Name: Shyne Brands
Labeler Code: 82018
Marketing Category: UNAPPROVED DRUG OTHER - 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: 06-15-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Estriol 5.0 Cream Product Label Images

Estriol 5.0 Cream 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

Otc - Active Ingredient

DRUG FACTSActive IngredientsMicronizrd Estriol USP (Wild Yam) .5%

Otc - Purpose

This is a topical cream that contains bio-identical estriol derived from wild yam. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes

Indications & Usage

USES:This is a topical cream that contains bio-identical estriol derived from wild yam. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes.DIRECTIONS:Apply once or twice a day. Massage into inner arms, thighs, chest or apply to inner forearm and rub arms together or use as directed by your Physician.

Warnings

For external cosmetic use only. If pregnant or nursing, consult a healthcare professional before using this product. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement:This product contains estrogen, a chemical known only to the state of California to cause cancer.KEEP OUT OF REACH OF CHILDREN.

Otc - Pregnancy Or Breast Feeding

If pregnant or nursing or if you have a serious medical condition consult a healthcare professional before using this product.

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children.

Dosage & Administration

Apply once or twice a day. Massage into inner arms, thighs, chest or apply to inner forearm and rub arms together or use as directed by you physician.

Inactive Ingredient

Purified Water, Vegetable Glycerin, Aloe Vera Gel,Caprylic/Capric Triglyceride,Stearic Acid,Olive Oil, Coconut Oil, Shea Butter, Sunflower Lecithin, Methylsulfonylmethane (MSM), Stearyl Alcohol,Isopropyl Palmitate,Allantoin,Carbomer,Sodium Bicarbonate, Herbal-Active® (Natural Preservative)

Otc - Questions

[email protected]

* Please review the disclaimer below.