NDC 82030-010 Soft Services Clearing Mist Breakout Tonic

Acne Treatment

NDC Product Code 82030-010

NDC CODE: 82030-010

Proprietary Name: Soft Services Clearing Mist Breakout Tonic 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: Acne Treatment 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.

NDC Code Structure

  • 82030 - A To Z International Corporation
    • 82030-010 - Soft Services Clearing Mist Breakout Tonic

NDC 82030-010-04

Package Description: 1 TUBE in 1 CARTON > 4 g in 1 TUBE

NDC Product Information

Soft Services Clearing Mist Breakout Tonic with NDC 82030-010 is a a human over the counter drug product labeled by A To Z International Corporation. The generic name of Soft Services Clearing Mist Breakout Tonic is acne treatment. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2560235.

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.

Soft Services Clearing Mist Breakout Tonic 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.


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)
  • ALCOHOL (UNII: 3K9958V90M)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • ZINC (UNII: J41CSQ7QDS)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: A To Z International Corporation
Labeler Code: 82030
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: 06-30-2021 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.

Soft Services Clearing Mist Breakout Tonic Product Label Images

Soft Services Clearing Mist Breakout Tonic 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

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

• for the treatment of acne

Warnings

For external use onlyUsing other topical acne medications at the same time or immediately following use of this


product may increase dryness or irritation of the skin. If this occurs, only one medication should


be used unless directed by a doctor.

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the skin thoroughly before applying this product • cover the entire


affected area with a thin layer one to three times daily • because 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 doctor • if bothersome dryness or peeling occurs, reduce


application to once a day or every other day.

Inactive Ingredients

Water, Alcohol Deant., Aloe Barbadensis Leaf Juice, Niacinamide, Zinc PCA, Melaleuca Alternifolia Leaf Oil, Glycerin, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Smilax Aristolochiaefolia Root Extrac, Citric Acid

* Please review the disclaimer below.