NDC 72197-015 Pharmacys Prescription 8 Oz Acne Control

Salicylic Acid

NDC Product Code 72197-015

NDC Code: 72197-015

Proprietary Name: Pharmacys Prescription 8 Oz Acne Control 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: Salicylic Acid 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

  • 72197 - American Consumer Products Corp
    • 72197-015 - Pharmacys Prescription 8 Oz Acne Control

NDC 72197-015-08

Package Description: 236.58 mL in 1 BOTTLE

NDC Product Information

Pharmacys Prescription 8 Oz Acne Control with NDC 72197-015 is a a human over the counter drug product labeled by American Consumer Products Corp. The generic name of Pharmacys Prescription 8 Oz Acne Control is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: American Consumer Products Corp

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.

Pharmacys Prescription 8 Oz Acne Control 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 .05 g/100mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SULISOBENZONE (UNII: 1W6L629B4K)
  • PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

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: American Consumer Products Corp
Labeler Code: 72197
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: 09-16-2019 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.

Pharmacys Prescription 8 Oz Acne Control Product Label Images

Pharmacys Prescription 8 Oz Acne Control 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

Active ingredient: Salicylic Acid 0.5%

Purpose

Purpose: Acne treatment
Uses: for the treatment of acne.

Warnings

Warnings: For external use only.
Flammable, keep away from open flame.

Keep Out Of Reach Of Children

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

Inactive Ingredients

Water (aqua), Alcohol (24.5%), Propylene Glycol, Glycerin, PEG-32, Algae Extract, DMDM Hydantoin, Dimethicone Propyl PG-Betaine, Sodium Citrate, Aloe Barbadensis Leaf Extract, Benzophenone-4, Denatonium Benzoate, Fragrance, FD&C Yellow No..5.

Directions

Directions: Wash face as you normally would and pat dry with a clean towel. Apply a small amount to cotton ball or pad and applyu using a dabbing motion. Take care to avoid rubbing in eyes. Use astringent two to three times daily or as directed by your doctor to keep your skin clear and healthy. Apply a light moisturizer after using astringent.

Instructions For Use

When using this product- avoid contact with eyes. If contact occurs, immediately flush with water.- using 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.

Indications & Usage

If bothersome drying or peeling occurs, reduce application.

* Please review the disclaimer below.