NDC 49527-713 Acne Solutions Oil Control Cleansing Mask Acne Medication All Skin Types

Salicylic Acid

NDC Product Information

Acne Solutions Oil Control Cleansing Mask Acne Medication All Skin Types with NDC 49527-713 is a a human over the counter drug product labeled by Clinique Laboratories Llc. The generic name of Acne Solutions Oil Control Cleansing Mask Acne Medication All Skin Types is salicylic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Clinique Laboratories Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Acne Solutions Oil Control Cleansing Mask Acne Medication All Skin Types 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 10 mg/mL

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: Clinique Laboratories Llc
Labeler Code: 49527
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: 12-10-2020 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’.

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Information for Patients

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

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Acne Solutions Oil Control Cleansing Mask Acne Medication All Skin Types Product Label Images

Acne Solutions Oil Control Cleansing Mask Acne Medication All Skin Types 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

Otc - Active Ingredient

ACTIVE INGREDIENT: 1.0% SALICYLIC ACID

Otc - Purpose

PURPOSE: ACNE TREATMENTUSE: FOR THE TREATMENT OF ACNE

Warnings

WARNING: FOR EXTERNAL USE ONLY.

Otc - When Using

  • WHEN USING THIS PRODUCT: USING OTHER TOPICAL ACNE DRUGS AT THE SAME TIME OR RIGHT AFTER 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.

Otc - 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.

Dosage & Administration

  • DIRECTIONS  APPLY EVENLY TO CLEAN SKIN, AVOIDING EYE AREALEAVE ON 5 MINUTESRINSE THOROUGHLY WITH WARM WATERIF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.

Inactive Ingredient

INACTIVE INGREDIENTS: WATER, KAOLIN, BUTYLENE GLYCOL, MAGNESIUM ALUMINUM SILICATE, SODIUM LAUROYL SARCOSINATE, GLYCERYL STEARATE, PEG-100 STEARATE, GENTIANA LUTEA (GENTIAN) ROOT EXTRACT, LAMINARIA SACCHARINA EXTRACT, SUCROSE, CHAMOMILLA RECUTITA (MATRICARIA), ALGAE EXTRACT, ALOE BARBADENSIS POWDER, ACETYL GLUCOSAMINE, INULIN, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, XANTHAN GUM, DISODIUM EDTA, CHLORPHENESIN, PHENOXYETHANOL, TITANIUM DIOXIDE  ILN34859

* Please review the disclaimer below.