NDC 71141-152 Oil Free Acne Wash

Salicylic Acid 2%

NDC Product Code 71141-152

NDC 71141-152-32

Package Description: 177 mL in 1 BOTTLE, PUMP

NDC Product Information

Oil Free Acne Wash with NDC 71141-152 is a a human over the counter drug product labeled by Lidl Us, Llc. The generic name of Oil Free Acne Wash is salicylic acid 2%. 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: 562600.

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.

Oil Free Acne Wash 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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
  • CHAMOMILE (UNII: FGL3685T2X)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

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: Lidl Us, Llc
Labeler Code: 71141
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: 02-10-2017 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".

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Oil Free Acne Wash Product Label Images

Oil Free Acne Wash 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

Keep Out Of Reach Of Children

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

Directions

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

Inactive Ingredients

Water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, glycerin, sodium chloride, decyl glucoside, disodium EDTA, fragrance, linoleamidopropyl PG-dimonium chloride phosphate, propylene glycol, Aloe barbadensis leaf extract, Anthemis nobilis flower extract, Chamomilla recutita (matricaria) flower extract, yellow 5, red 40

Adverse Reactions Section

DISTRIBUTED BYLidl US, LLC3500 S. Clark StreetArlington, VA 22202QUESTIONS?1-844-344-5071www.lidl.com947.003/947AC

* Please review the disclaimer below.