NDC 81716-004 Subir Eyelash

Biotin

NDC Product Code 81716-004

NDC 81716-004-01

Package Description: .7 g in 1 POUCH

NDC Product Information

Subir Eyelash with NDC 81716-004 is a a human over the counter drug product labeled by Dream Polymer. The generic name of Subir Eyelash is biotin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Dream Polymer

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.

Subir Eyelash 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.

  • BIOTIN .07 g/.7g

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.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)

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.

Product Labeler Information

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

Labeler Name: Dream Polymer
Labeler Code: 81716
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: 03-30-2021 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.

Subir Eyelash Product Label Images

Subir Eyelash 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

Active Ingredient(S)

Biotin 10%D-Panthenol 8%

Purpose

Anti-static, Hair conditioning, Skin conditioning

Use

Subir Eyelash Biotin Cream for eyelash damage care

Warnings

• Be careful not to get in your eyes.• If it gets into your eyes, immediately wash it off with clean water several times.• Wear appropriate gloves during the procedure.• Do not eat.• Keep out of reach of children.• Store in a cool place away from direct sunlight.• Recommended for single use only.• For professional use only.• Follow the recommendations.• After use, if skin irritation such as rash or itching persists, stop use and consult a doctor or pharmacist

Otc - Keep Out Of Reach Of Children

 Keep out of reach of children.

Directions

• Using a Brush follow the same steps used for applying the perm and setting creams to applying the Essence (nourishing agent).• Let nourishing set for five minutes.• Prevents eyelash damage and promotes growth.

Other Information

・ Store in room temperature 0~30℃・ Avoid direct sunlight.

Inactive Ingredients

Water, Propylene Glycol(PG), Acrus Calamus Rhizome Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Chamaecyparis Obtusa Leaf Extract, Olea Europaea (Olive) Leaf Extract, Espinosilla Extract, Decametyl Tetra Siloxane, Fragrance

* Please review the disclaimer below.