NDC 69435-1904 Gold Cosmetics Adi Clear

Hydroquinone Cream

NDC Product Code 69435-1904

NDC 69435-1904-1

Package Description: 30 mL in 1 TUBE

NDC Product Information

Gold Cosmetics Adi Clear with NDC 69435-1904 is a a human over the counter drug product labeled by Peer Pharm Ltd. The generic name of Gold Cosmetics Adi Clear is hydroquinone cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Peer Pharm Ltd

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 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.

Gold Cosmetics Adi Clear 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 5 mg/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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • JOJOBA OIL (UNII: 724GKU717M)
  • DECYL OLEATE (UNII: ZGR06DO97T)
  • SODIUM DITHIONATE (UNII: RPF7Z41GAW)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • WATER (UNII: 059QF0KO0R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CETEARETH-30 (UNII: 1R9DCZ5FOX)
  • STEARETH-21 (UNII: 53J3F32P58)
  • STEARETH-2 (UNII: V56DFE46J5)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Peer Pharm Ltd
Labeler Code: 69435
FDA Application Number: part358A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-06-2019 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.

Gold Cosmetics Adi Clear Product Label Images

Gold Cosmetics Adi Clear 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

Hydroquinone 5%

Otc - Purpose

Face cream for gradual fading of dark spots

Indications & Usage

Face cream for gradual fading of dark spotsApply a very thin layer once a day, only at night, all over the face

Dosage & Administration

Apply a very thin layer once a day, only at night, all over the face​

Warnings

Warnings:

Sun exposure should be limit by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin

when using and after using this product in order to prevent darkening from reoccurring.

Proper use of skin bleaching creams is extremely important, and directions should be followed carefully at all times.

Large skin areas, such as the entire face, should not be bleached at once due to the possibility of skin discoloration.

Product should be used on the darkened area of skin only.

For external use only.

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

* Please review the disclaimer below.