NDC 71718-500 Saliskin

Salicylic Acid

NDC Product Information

Saliskin with NDC 71718-500 is a a human over the counter drug product labeled by Scientific Solutions Global Llc. The generic name of Saliskin is salicylic acid. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Scientific Solutions Global Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Saliskin 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 1.66 g/1.66g

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.

  • TEA TREE OIL (UNII: VIF565UC2G)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)

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: 10-04-2019 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.

Saliskin Product Label Images

Saliskin 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, TEA TREE OIL

Inactive Ingredient

MEDIDERM CREAM, GREEN TEA EXTRACT, ALOE VERA, EMULTHIX

Dosage & Administration

WASH FACE THOROUGHLY AND APPLY TO AFFECTED AREAS. USE CONTINUOUSLY FOR AT LEAST 12 WEEKS FOR OPTIMAL RESULTS

Warnings

FOR EXTERNAL USE ONLY.AVOID CONTACT TO EYES.KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOOCCURS.

Otc - Purpose

REMOVES PIMPLESMINIMIZES PORESENHANCED WITH TEA TREE OIL AND ALOE VERA

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH FO CHILDREN

Indications & Usage

USE CONTINUOUSLY FOR AT LEAST 12 WEEKS FOR OPTIMAL RESULTS

* Please review the disclaimer below.