NDC 73428-1001 Body Merry Lightening And Whitening Cream

Hydroquinone

NDC Product Code 73428-1001

NDC CODE: 73428-1001

Proprietary Name: Body Merry Lightening And Whitening Cream What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydroquinone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, liver spots, age spots, freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin. This medicine works by blocking the process in the skin that leads to discoloration.

NDC Code Structure

  • 73428 - Body Merry, Llc
    • 73428-1001 - Body Merry Lightening And Whitening Cream

NDC 73428-1001-1

Package Description: 100 mL in 1 JAR

NDC Product Information

Body Merry Lightening And Whitening Cream with NDC 73428-1001 is a a human over the counter drug product labeled by Body Merry, Llc. The generic name of Body Merry Lightening And Whitening Cream is hydroquinone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Body Merry, 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 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.

Body Merry Lightening And Whitening Cream 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 .02 g/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

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: Body Merry, Llc
Labeler Code: 73428
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: 11-14-2019 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.

Body Merry Lightening And Whitening Cream 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/Purpose:

Hydroquinone 2.0% Skin Lightener

Active Ingredient/Purpose:

Skin Lightener

Warnings:

For external use only. Do not use on inflammed or broken skin. When using this product, avoid contact with the eyes. If contact occurs, rinse thoroughly with water. Avoid unnecessary sun exposure and use a sunscreen or protective clothing. Stop use and consult a doctor if irritation becomes severe. If pregnant or breastfeeding, consult a physician before use. Keep out of reach of children.

Uses

For gradual fading of hyperpigmented areas of the skin. Helps fade away dark spots on the skin.

Directions:

Apply onto cleansed skin of the affected area or as directed by a physician. Not recommended for children under 12 years of age.

Inactive Ingredients:

Water, glyceryl streate, PEG-100 stearate, stearic acid

Warning

Keep out of reach of children.

* Please review the disclaimer below.