NDC 69842-821 Acne Scrub

Salicylic Acid

NDC Product Information

Acne Scrub with NDC 69842-821 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Acne Scrub is salicylic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cvs Pharmacy

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 Scrub 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 20 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)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • GRAPEFRUIT (UNII: O82C39RR8C)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)
  • AGAR (UNII: 89T13OHQ2B)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

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 Pharmacy
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: 12-30-2020 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: 12-31-2022 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 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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Acne Scrub Product Label Images

Acne Scrub 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%)

Purpose

Acne medication

Use

For the treatment 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.avoid contact with eyes.  If contact occurs, flush thoroughly with water

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison control Center right away

Directions

  • Use up to twice daily.  Wet face, apply to hands, add water and work into a lather.  Massage face gently. Rinse wellavoid contact with the eyes.  If contact occurs, flush thoroughly with water.

Inactive Ingredients

Water, sodium C14-16 olefin sulfonate, glycerin, cocamidopropyl betaine, acrylates copolymer, sodium chloride, microcrystalline cellulose, cellulose, carrageenan, C12-15 alkyl lactate, disodium EDTA, cocamidopropyl PG-dimonium chloride phosphate, Citrus grandis (grapefruit) fruit extract, polyquaternium-7, Camellia sinensis leaf extract, ascorbyl palmitate, neopentyl glycol dicaprylate/dicaprate, Anthemis nobilis flower extract, polysorbate 20, polyvinyl alcohol, propylene glycol, benzalkonium chloride, butylene glycol, sodium benzotriazolyl butylphenol sulfonate, agar, mica, titanium dioxide, sodium hydroxide, fragrance, red 30, red 40, ext. violet 2

Adverse Reaction

Distributed by: CVS Pharmacy, IncOne CVS Drive, Woonsocket, RI 02895©2020 CVS/pharmacyCVS.com 1-800-SHOP CVSMade in the U.S.A. with U.S. and foreign componentsV-12339CVS QualityMoney Back Guarantee

Disclaimer

*This product is not manufactured or distributed by Neutorgena Corporation, distributor of Oil-Free Acne Wash Pink Grapefruit Foaming Scrub

* Please review the disclaimer below.