NDC 71790-002 G9 Skin Ac Solutioncleanser

Salicylic Acid

NDC Product Code 71790-002

NDC 71790-002-01

Package Description: 120 mL in 1 BOTTLE

NDC Product Information

G9 Skin Ac Solutioncleanser with NDC 71790-002 is a a human over the counter drug product labeled by Cosmelab Co., Ltd.. The generic name of G9 Skin Ac Solutioncleanser is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cosmelab 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.

G9 Skin Ac Solutioncleanser 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.

  • SALICYLIC ACID .5 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)
  • 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.

  • 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: Cosmelab Co., Ltd.
Labeler Code: 71790
FDA Application Number: part333D What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-01-2019 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: 12-31-2020 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.

G9 Skin Ac Solutioncleanser Product Label Images

G9 Skin Ac Solutioncleanser 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

Salicylic acid

Inactive Ingredient

Water, Glycerin, Palmitic Acid, Stearic Acid, Lauric Acid, Myristic Acid, Potassium Hydroxide, Glyceryl Stearate SE, Cocamide DEA, Propylene Glycol, Beeswax, Cocamidopropyl Betaine, Glycol Distearate, PEG-60 Hydrogenated Castor Oil, Phenoxyethanol, Fragrance, Sodium Chloride, Chlorphenesin, Centella Asiatica Extract, Tocopheryl Acetate, Alcohol, Disodium EDTA, BHT, Butylene Glycol, Eucalyptus Globulus Leaf Extract, Sophora Angustifolia Root Extract, 1,2-Hexanediol, Hamamelis Virginiana (Witch Hazel) Extract, Citrus Paradisi (Grapefruit) Fruit Extract

Otc - Purpose

For Sensitive and troubled skin, specially ACNE skin type care

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

■ following the use of base, take a suitable amount on the back of your hand and apply it over your face thinly following skin texture■ gently rub with your fingers as like doing massage and wash off the remains

Warnings

■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialistred specks, swelling, itching■ don’t use on the part where there is injury, eczema, or dermatitisKeep out of reach of children■ if swallowed, get medical help or contact a person control center immediately

Dosage & Administration

For external use only

* Please review the disclaimer below.

Previous Code
71790-001
Next Code
71790-003