NDC 73010-900 Humane Acne Wash

Benzoyl Peroxide

NDC Product Code 73010-900

NDC 73010-900-00

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Humane Acne Wash with NDC 73010-900 is a a human over the counter drug product labeled by Apprendista, Llc. The generic name of Humane Acne Wash is benzoyl peroxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Apprendista, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Humane Acne Wash 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.

  • BENZOYL PEROXIDE 100 mg/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)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Apprendista, Llc
Labeler Code: 73010
FDA Application Number: part333D 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-01-2019 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.

Humane Acne Wash Product Label Images

Humane Acne Wash 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 Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only.

Do Not Use

  • If you are sensitive to Benzoyl Peroxide or have very sensitive skin.Using other topical acne drugs at the same time or right after use of this product may increase dryness, redness or irritation of the skin.Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

When Using This Product

  • Avoid contact with and near eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.Avoid unnecessary sun exposure and use a sunscreen.Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop Use And Ask A Doctor

If excessive irritation occurs.

Keep Out Of Reach Of Children.

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

Directions

New User: Test 1-2 small affected areas for sensitivity for 3 days. If no discomfort occurs, apply acne wash and gently massage into damp skin. Wait 3-5 minutes for wash to absorb. Rinse thoroughly.

Inactive Ingredients

Aqua (Deionized Water), Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide.

* Please review the disclaimer below.

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