NDC 73453-166 Ambi Even And Clear Exfoliating Wash Acne Treatment

Salicylic Acid

NDC Product Information

Ambi Even And Clear Exfoliating Wash Acne Treatment with NDC 73453-166 is a a human over the counter drug product labeled by Ambi Enterprises, Llc. The generic name of Ambi Even And Clear Exfoliating Wash Acne Treatment is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ambi Enterprises, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Ambi Even And Clear Exfoliating Wash Acne Treatment 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.

  • SALICYLIC ACID 15 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.

  • WATER (UNII: 059QF0KO0R)
  • DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • ZINC PIDOLATE (UNII: C32PQ86DH4)
  • MYRISTIC ACID (UNII: 0I3V7S25AW)
  • OAT (UNII: Z6J799EAJK)
  • PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
  • ETHYL VANILLIN (UNII: YC9ST449YJ)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

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: Ambi Enterprises, Llc
Labeler Code: 73453
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: 07-13-2020 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: 12-31-2021 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.

Ambi Even And Clear Exfoliating Wash Acne Treatment Product Label Images

Ambi Even And Clear Exfoliating Wash Acne Treatment 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

Salicylic acid 1.5%

Purpose

Acne Treatment

Use

For the treatment of acne

Warnings

For external use only

When Using This Product

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

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

Directions

  • Use every morning and eveningwet area firstapply a dime sized amount to palm and create a lather.gently massage over the face and neckrinse well may also be used on chest and backbecause excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredients

Aqua (deionized water), disodium laureth sulfosuccinate, sodium cocoyl isetionate, cocamidopropyl betaine, sodium cocoyl taurate, polyacrylate-1 crosspolymer, sodium lauroamphoacetate, stearic acid, jojoba esters, salicylic acid, glycol stearate, zinc PCA, myristic acid, aminomethyl propanol avena sativa (oat) protein, sea whip extract, ethyl vanillin, dehydroacetic acid, benzyl alcohol.

Other Information

Store at 59°-86°F (15°-30°C)

* Please review the disclaimer below.