NDC 71484-0010 Hair Essence

Camellia Japonica Seed Oil, Argania Spinosa Kernel Oil

NDC Product Code 71484-0010

NDC 71484-0010-1

Package Description: 50 mL in 1 BOTTLE

NDC Product Information

Hair Essence with NDC 71484-0010 is a a human over the counter drug product labeled by Ddoruroo Co., Ltd.. The generic name of Hair Essence is camellia japonica seed oil, argania spinosa kernel oil. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ddoruroo Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Hair Essence 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.

  • MORINGA OLEIFERA LEAF 1 g/100mL
  • CALENDULA OFFICINALIS FLOWER 1 g/100mL

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)

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: Ddoruroo Co., Ltd.
Labeler Code: 71484
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: 03-04-2020 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.

Hair Essence Product Label Images

Hair Essence 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

Camellia Japonica Seed Oil

Argania Spinosa Kernel Oil

Dimethicone

Oryza Sativa (Rice) Bran Oil

Silk Amino Acids

Hydrolyzed Keratin

Acorus Calamus Root Extract

Moringa Oleifera Leaf Extract

Hibiscus Syriacus Flower Extract

Calendula Officinalis Flower Extract

Anthemis Nobilis Flower Extract

Centella Asiatica Extract

Rosmarinus Officinalis (Rosemary) Extract

Mentha Haplocalix Extract

Punica Granatum Fruit Extract

Citrus Limon (Lemon) Fruit Extract

Pyrus Malus (Apple) Fruit Extract

Lycium Chinense Fruit Extract

Inactive Ingredient

Acorus Calamus Rhizome Water

Glycerin
1,2-HexanediolFragrance

Carbomer

Arginine

Ethylhexylglycerin

Caprylyl glycol

Otc - Purpose

For all hair types, repair & protect hair & scalp

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

Indications & Usage

Apply to entire scalp or desired area and gently massage with fingertips

Warnings

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children

Dosage & Administration

For external use only

* Please review the disclaimer below.