NDC 71718-213 Urea 40 Plus Ha

Urea

NDC Product Code 71718-213

NDC 71718-213-01

Package Description: 113 g in 1 JAR

NDC 71718-213-02

Package Description: 113 g in 1 BOTTLE, DISPENSING

NDC 71718-213-03

Package Description: 226 g in 1 BOTTLE, DISPENSING

NDC Product Information

Urea 40 Plus Ha with NDC 71718-213 is a a human over the counter drug product labeled by Scientific Solutions Global Llc. The generic name of Urea 40 Plus Ha is urea. The product's dosage form is gel and is administered via topical form.

Labeler Name: Scientific Solutions Global Llc

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.

Urea 40 Plus Ha 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.

  • UREA 40 g/113g

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.

  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • WATER (UNII: 059QF0KO0R)
  • TRIDECETH-10 (UNII: G624N6MSBA)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)

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: 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: 09-20-2019 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.

Urea 40 Plus Ha Product Label Images

Urea 40 Plus Ha 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

Active Ingredients:

UREA

Otc - Purpose

SOOTHES ROUGH & DRY SKINHEALS CORNS & CALLOUSESSOFTENS NAILS

Indications & Usage

SOOTHES ROUGH & DRY SKIN

Safe Handling Warning

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 REOCCURS.KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Instructions For Use

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.

Inactive Ingredient

ALOE VERA, CARBOMER, COCONUT OIL, EMULSIFIERS, GREEN TEA, MINERAL OIL, PRESERVED WATER, POPYLENE GLYCOL, SODIUM HYALURONATE, TEA TREE OIL, TRIETHANOLOAMINE, XANTHAM GUM

Storage And Handling

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

Other Safety Information

ENHANCED WITH TEA TREE OIL & ALOE VERA

Dosage & Administration

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

Warnings

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

* Please review the disclaimer below.