NDC 71718-703 Glycolic Acid

Pari 70% Glycolic Acid Peel

NDC Product Code 71718-703

NDC 71718-703-01

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Glycolic Acid with NDC 71718-703 is a a human over the counter drug product labeled by Scientific Solutions Global Llc. The generic name of Glycolic Acid is pari 70% glycolic acid peel. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Scientific Solutions Global Llc

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.

Glycolic Acid 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.

  • GLYCOLIC ACID .7 1/9mL

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.

  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)

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: Scientific Solutions Global Llc
Labeler Code: 71718
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: 10-03-2019 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.

Glycolic Acid Product Label Images

Glycolic Acid 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

Ingredients

Glycolic Acid

Otc - Purpose

FOR SKIN PRONE TO BREAKOUTS

FOR AGING SKIN

FOR SKIN PRONE TO BREAKOUTS

FOR AGING SKIN

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Warnings

CAUTION

For external use only. Avoid contact with eyes and\ mucous membranes. In case of contact with eyes, flush with water. Some users may experience mild skin irritation. If irritation or redness lingers after rinsing, discontinue use and seek medical attention. Use caution when applying a solution stronger than 10% below the neckline. Keep out of reach of children.

Instructions For Use

DIRECTIONS

Cleanse area to be exfoliated
Use sterile gauze to apply a thin layer of acid peel to the skinWait for 60 to 90 seconds (20 seconds for first use; 20 to 60 seconds on sensitive skin)Rinse with cool waterRepeat weekly until desired resultsApply sunscreen to any exfoliated areas for extra protection

Inactive Ingredient

Hydroxyethyl Cellulose

Dosage & Administration

Cleanse area to be exfoliated
Use sterile gauze to apply a thin layer of acid peel to the skin

Wait for 60 to 90 seconds (20 seconds for first use; 20 to 60 seconds on sensitive skin)

Rinse with cool water

Repeat weekly until desired results

Apply sunscreen to any exfoliated areas for extra protection

Indications & Usage

FOR SKIN PRONE TO BREAKOUTS

FOR AGING SKIN

* Please review the disclaimer below.