NDC 73085-0001 Pimplepatch By Glam Up

Salicylic Acid

NDC Product Code 73085-0001

NDC 73085-0001-1

Package Description: 1 KIT in 1 CARTON * 2 mg in 1 PATCH (73085-0003-2) * 2 mg in 1 PATCH (73085-0002-1) * 1 mg in 1 PATCH (73085-0003-1)

NDC Product Information

Pimplepatch By Glam Up with NDC 73085-0001 is a a human over the counter drug product labeled by Spigen Korea Co., Ltd.. The generic name of Pimplepatch By Glam Up is salicylic acid. The product's dosage form is kit and is administered via form.

Labeler Name: Spigen Korea Co., Ltd.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Product Labeler Information

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

Labeler Name: Spigen Korea Co., Ltd.
Labeler Code: 73085
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: 05-10-2019 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.

Pimplepatch By Glam Up Product Label Images

Pimplepatch By Glam Up 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 aid

Inactive Ingredient

Sodium Hyaluronate, Niacinamide, Sh-Oligopeptide-1, Sh-Polypeptide-1, TetraPeptide-44, Centella Asiatica Extract, Tranexamic Acid, Camellia Japonica Flower Extract, etc

Otc - Purpose

Target trouble spot/acne early, quickly and easily

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Step 1. microneedle patch1. after cleansing apply onto dry skin, press lightly for 10 seconds and leave on for 2~3 hours2. do not repeatedly apply on same area (make sure the needle area of the patch avoids water)step 2. hydrocolloid1. after cleansing apply on to dry skin, pick the suitable hydrocolloid patch size and apply on trouble spot2. for faster healing of trouble spot(s), avoid repeatly changing patches. use the small patch size for areas that are difficult to reach (i.e., side of nose)

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.