NDC 73318-1065 Salicylic Acid Spot Treatment

Spot Treatment

NDC Product Code 73318-1065

NDC 73318-1065-9

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 9 g in 1 BOTTLE, PLASTIC

NDC Product Information

Salicylic Acid Spot Treatment with NDC 73318-1065 is a a human over the counter drug product labeled by Skin Ps Brands. The generic name of Salicylic Acid Spot Treatment is spot treatment. The product's dosage form is lotion and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 103568.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Salicylic Acid Spot 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.


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.

  • HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: Skin Ps Brands
Labeler Code: 73318
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: 06-23-2021 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.

Salicylic Acid Spot Treatment Product Label Images

Salicylic Acid Spot 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 2.0%

Purpose

Acne Treatment

Use

For the management 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.

Directions

  • Clean skin thoroughly before applying this productcover the entire affected area with a thin layer one to three times dailybecause excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three daily if needed or as directed by a doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other daySensitivity Test for a New User:​Apply product sparingly to one or two small affected areas during the first 3 days. if no discomfort occurs, follow the directions stated above.

Inactive Ingredients

Alcohol Denat., Aqua/Water/Eau, Hamamelis Virginiana (Witch Hazel) Extract, Camphor.

Salicylic Acid Spot Treatment

Small but mighty, this is our original pimple stopper. Maximum strength Salicylic Acid treats blackheads and whiteheads while soothing all types of pimples. It reduces redness and irritation, plus helps blemishes heal. This quick drying formula goes on clear so it can be used day or night, over or under makeup. Hello on-the-go-zit-zapping.

How To Use:

Apply a thin layer to affected area. Reapply as needed.

Slmd Sandra Lee Md

Skin Care by Dr. Pimple PopperSalicylic Acid Spot TreatmentAcne TreatmentMaximum Strength 2%0.3 fl. oz. / 9 mLUnit Carton:Primary Unit:

* Please review the disclaimer below.