NDC 69842-077 Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask

Salicylic Acid

NDC Product Information

Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask with NDC 69842-077 is a a human over the counter drug product labeled by Cvs Health. The generic name of Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cvs Health

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.

Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask 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 5 mg/mL

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)
  • KAOLIN (UNII: 24H4NWX5CO)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BENTONITE (UNII: A3N5ZCN45C)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CAFFEINE (UNII: 3G6A5W338E)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • LEVOMENOL (UNII: 24WE03BX2T)

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: Cvs Health
Labeler Code: 69842
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: 07-01-2016 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.

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]

* Please review the disclaimer below.

Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask Product Label Images

Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask 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 0.5%

Purpose

Acne

Use

For the management of acne

Warnings

For external use only

When Using This Product

  • 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.
  • Avoid contact with eye. if contact occurs, flush thoroughly with water.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Once to twice per week, apply a generous layer evenly onto cleansed skin avoiding the eye area.
  • Leave on for 10 minutes.
  • Rinse thoroughly with water.
  • Follow with your favorite Skin+Pharmacy moisturizer.

Inactive Ingredients

Water, Kaolin, Glycerin, Bentonite, Butylene Glycol, Cetearyl Alcohol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cocamidopropyl Betaine, PEG-100 Stearate, Magnesium Aluminum Silicate, Glyceryl Stearate, Phenoxyethanol, Ceteareth-20, Xanthan Gum, Chlorphenesin, Caffeine, Ethylhexylglycerin, Disodium EDTA, Citric Acid, Sodium Hydroxide, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Bisabolol.
Microsponge® is a registered trademark of AMCOL International Corp.
Save carton for complete labeling since all warnings are not included on the inner package.
Distributed by: CVS Pharmacy, Inc.One CVS Drive, Woonsocket, RI 02895
© 2016 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in the U.S.A. of U.S. and foreign components
V-13649
CVS®
QualityMoney Back Guarantee
M050873CP
FP419
#742825

* Please review the disclaimer below.