NDC 43479-111 Eradikate Salicylic Acid Acne Treatment

Salicylic Acid

NDC Product Code 43479-111

NDC CODE: 43479-111

Proprietary Name: Eradikate Salicylic Acid Acne Treatment What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Salicylic Acid What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

NDC Code Structure

  • 43479 - Kate Somerville Skincare, Llc
    • 43479-111 - Eradikate Salicylic Acid Acne Treatment

NDC 43479-111-51

Package Description: 1 BOTTLE in 1 BOX > 30 mL in 1 BOTTLE (43479-111-11)

NDC Product Information

Eradikate Salicylic Acid Acne Treatment with NDC 43479-111 is a a human over the counter drug product labeled by Kate Somerville Skincare, Llc. The generic name of Eradikate Salicylic Acid Acne Treatment is salicylic acid. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Kate Somerville Skincare, Llc

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.

Eradikate Salicylic Acid Acne 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.

  • SALICYLIC ACID 2 g/100mL

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)
  • GLYCERETH-7 TRIMETHYL ETHER (UNII: XMC7402M60)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
  • TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)
  • STEARETH-21 (UNII: 53J3F32P58)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • STEARETH-2 (UNII: V56DFE46J5)
  • RETINYL PROPIONATE (UNII: 32JK994WMC)
  • HEXYLRESORCINOL (UNII: R9QTB5E82N)
  • OLIGOPEPTIDE-10 (UNII: Q46328TRNK)
  • PROLINE (UNII: 9DLQ4CIU6V)
  • HYDROXYPROLINE (UNII: RMB44WO89X)
  • ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • LAMINARIA DIGITATA (UNII: 15E7C67EE8)
  • BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
  • HONEY (UNII: Y9H1V576FH)
  • RICE BRAN (UNII: R60QEP13IC)
  • CHLORELLA VULGARIS (UNII: RYQ4R60M02)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERETH-18 (UNII: SA5E43C17C)
  • TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • DISODIUM CARBOXYETHYL SILICONATE (UNII: 4U4C79679G)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)

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: Kate Somerville Skincare, Llc
Labeler Code: 43479
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: 11-18-2018 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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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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Eradikate Salicylic Acid Acne 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 Ingredients

SALICYLIC ACID- 2%

Purpose

ACNE MEDICATION

Uses

  • FOR THE TREATMENT OF ACNEHELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES

Warnings

FOR EXTERNAL USE ONLY

Otc - When Using

  • WHEN USING THIS PRODUCTUSING OTHER TOPICAL  ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE 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 EYES. IF EXCESSIVE SKIN IRRITATION DEVELOPS OR INCREASES, DISCONTINUE USE AND CONSULT A DOCTOR.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Dosage & Administration

  • USE 1 TO 2 TIMES WEEKLYGENTLY APPLY AN EVEN LAYER TO CLEAN, WET SKIN USING CIRCULAR MOTIONSLEAVE ON FOR 1 MINUTEGENTLY WASH OFF AND PAT DRY.

Other Information

  • DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKINYOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PT

Inactive Ingredients

Water, Glycereth-7 Trimethyl Ether, Cetyl Alcohol, Caprylic/Capric Triglyceride, Isopropyl Isostearate,Trimethylolpropane Tricaprylate/Tricaprate, Steareth-21, Dimethicone, Glycereth-18 Ethylhexanoate, Propanediol, Steareth-2, Retinyl Propionate, Hexylresorcinol, Oligopeptide-10, Proline, Hydroxyproline, Ethyl Linoleate, Sodium Hyaluronate, Saccharide Isomerate, Sodium PCA, Panthenol, Melaleuca Alternifolia Leaf Oil, Laminaria Digitata Extract, Boswellia Serrata Extract, Honey Extract, Oryza Sativa (Rice) Bran Extract, Chlorella Vulgaris Extract, Sea Water, Glycerin, Butylene Glycol, Glycereth-18, Trimethylpentanediol/Adipic Acid Copolymer, 1,2-Hexanediol, Polyacrylate Crosspolymer-6, Polymethylsilsesquioxane/Silica Crosspolymer, Aminomethyl Propanol, Caprylhydroxamic Acid, Disodium EDTA, Phenoxyethanol, Sodium Benzoate, Ethylhexylglycerin, Lavandula Angustifolia (Lavender) Oil, Disodium Carboxyethyl Siliconate, T-Butyl Alcohol, Linalool, Limonene, Iron Oxides (Ci 77491).

* Please review the disclaimer below.