NDC 68723-142 Skin Lightener

Hydroquinone

NDC Product Code 68723-142

NDC 68723-142-02

Package Description: 1 BOTTLE in 1 BOX > 57 g in 1 BOTTLE

NDC Product Information

Skin Lightener with NDC 68723-142 is a a human prescription drug product labeled by Axia Medical Solutions, Llc. The generic name of Skin Lightener is hydroquinone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Axia Medical Solutions, Llc

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 Lightener 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 40 mg/g

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.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • CAULOSIDE D (UNII: 4N5Z068GAZ)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)

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: Axia Medical Solutions, Llc
Labeler Code: 68723
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: 12-01-1990 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Skin Lightener 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

Other

RX OnlyFOR EXTERNAL USE ONLY

Distributed ByAxia Medical Solutions     Carlsbad, California 92011

Description

DERMESSE SKIN LIGHTENER contains: Hydroquinone 40mg/gm.  See label on bottle for complete list of ingredients.  Following is its chemical structure:

Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic hydroquinone. oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes. The selective inhibition of the enzyme affects melanogenesis in the melanocytes resulting in cessation of melanin formation and subsequent reduction in pigmentation.  Additional studies indicate Hydroquinone acts on the essential subcellular metabolic processes of melanocytes with resultant cytolysis, i.e. nonenzymediated depigmentation.Exposure to sunlight or ultraviolet light will cause regimentation of the bleached areas, which may be prevented by the use of sunblocking agents.

Indications And Usage

DERMESSE SKIN LIGHTENER is indicated for the gradual bleaching of hyperpigmented skin conditions such as chlosma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.

Contraindications

Prior history of sensitivity or allergic reaction to this product or any of its ingredients.  The safety of topical Hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Warnings

  • CAUTION: Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.Test for skin sensitivity before using Hydroquinone Cream by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching and vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician.  A bitter taste and anesthetic effect may occur if applied to lips.  Keep out of reach of children.  If no bleaching or lightening effect is noted after 2 months of treatment use, Hydroquinone Cream should be discontinued. This product is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.Sunscreen use is an essential aspect of Hydroquinone therapy because even minimal sunlight sustains melanocytic activity.  After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a sunscreen or sunblock agent, or protective clothing to prevent repigmentation.  There are no sunblocking or sunscreening agents in DERMESSE SKIN LIGHTENER and since minimal sunlight exposure may reverse the bleaching effect of this preparation.  It should be used only at night or on areas of the body covered by protective clothing.  During the daytime, sunblocking or broad spectrum sunscreen preparations or protective clothing should be used to prevent the bleached areas from repigmentation.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Warning: Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons.

Precautions

See Warnings

A. Pregnancy Category C

Animal reproduction studies have not been conducted with topical Hydroquinone. It is also not known whether Hydroquinone can cause fetal harm when used topically on a pregnant woman or can affect reproductive capacity.  It is not known to what degree, if any, topical Hydroquinone is absorbed systemically.  Topical Hydroquinone should be used in women only when clearly indicated.

B. Nursing Mothers

It is not known whether topical Hydroquinone is absorbed or excreted in human milk. Caution is advised when topical Hydroquinone is used by a nursing mother.

C. Pediatric Usage

Safety and effectiveness in children below the age of 12 years have not been established.

Adverse Reactions

No systemic reactions have been reported. Occasional cutaneous hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately

Overdosage

There have been no systemic reactions reported from the use of topical Hydroquinone. However, treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

Drug Dosage And Adminstration

A thin application of DERMESSE SKIN LIGHTENER should be applied to the affected area twice daily or as directed by a physician.  Consult product label for instructions on whether to rub in or not.  There is no recommendation for children under the age of 12 years of age except under the advice and supervision of a physician.

How Supplied

DERMESSE SKIN LIGHTENER is available as follows:2 Oz. (57g) bottle

Storage And Handling

DERMESSE SKIN LIGHTENER should be stored at controlled room temperature (15°-30°C) (59°-86°F).  Darkening of this product is normal.  This will not affect performance or safety.

* Please review the disclaimer below.