NDC 70484-101 Skin Lightening Complex

Hydroquinone

NDC Product Code 70484-101

NDC Product Information

Skin Lightening Complex with NDC 70484-101 is a a human prescription drug product labeled by Vi Medical Products Inc.. The generic name of Skin Lightening Complex is hydroquinone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Vi Medical Products Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription 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.

Skin Lightening Complex 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.

  • HYDROQUINONE 4 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.

  • ARBUTIN (UNII: C5INA23HXF)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • AZELAIC ACID (UNII: F2VW3D43YT)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • KOJIC DIPALMITATE (UNII: 13N249RWTM)
  • MALIC ACID (UNII: 817L1N4CKP)
  • MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
  • METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Melanin Synthesis Inhibitor - [EPC] (Established Pharmacologic Class)
  • Melanin Synthesis Inhibitors - [MoA] (Mechanism of Action)
  • Depigmenting Activity - [PE] (Physiologic Effect)

Product Labeler Information

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

Labeler Name: Vi Medical Products Inc.
Labeler Code: 70484
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: 07-28-2019 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.

Skin Lightening Complex 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

Use

HELPS LIGHTEN DARK PATCHES OF SKIN SUCH AS AGE SPOTS, MELASMA, FRECKLES AND HYPERPIGMENTATION THAT CAN OCCUR AS A RESULT OF PREGNANCY, USE OF ORAL CONTRACEPTIVES OR INJURY TO THE SKIN. RX ONLY. FOR EXTERNAL USE ONLY.

* Please review the disclaimer below.

Previous Code
70484-006
Next Code
70486-001