NDC 71484-0009 Moringa Showergel

Silk Amino Acids, Moringa Oleifera Leaf Extract

NDC Product Code 71484-0009

NDC 71484-0009-1

Package Description: 300 mL in 1 BOTTLE

NDC Product Information

Moringa Showergel with NDC 71484-0009 is a a human over the counter drug product labeled by Ddoruroo Co., Ltd.. The generic name of Moringa Showergel is silk amino acids, moringa oleifera leaf extract. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ddoruroo Co., Ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Moringa Showergel 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
  • AMINO ACIDS, SILK 1.2 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’.

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Moringa Showergel Product Label Images

Moringa Showergel 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

Silk Amino Acids

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
Allantoin

Oryza Sativa (Rice) Bran Oil

Cnidium Monnieri Fruit Extract

Hyaluronic Acid

Arctium Lappa Seed Extract

Inactive Ingredient

Moringa Oleifera Leaf Water

Water

Decyl Glucoside

Lauryl Glucoside

Sodium Cocoyl Apple Amino Acids

Glycerin
Fragrance

Butylene Glycol

PEG-120 Methyl Glucose Dioleate

Polyquaternium-10

Citric Acid

1,2-Hexanediol

Ethylhexylglycerin

Caprylyl glycol
hyaluronic acid

Otc - Purpose

For washing to nourish and skin softening on the skin

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

Indications & Usage

Pour onto wet hands or body sponges, work into a lather, and rinse it off

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

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