NDC 72935-001 Neora Complexion Clearing

Salicylic Acid

NDC Product Code 72935-001

NDC 72935-001-45

Package Description: 1 JAR in 1 CARTON > 45 APPLICATOR in 1 JAR > 1.1 mL in 1 APPLICATOR

NDC Product Information

Neora Complexion Clearing with NDC 72935-001 is a a human over the counter drug product labeled by Neora, Llc. The generic name of Neora Complexion Clearing is salicylic acid. The product's dosage form is swab and is administered via topical form.

Labeler Name: Neora, Llc

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

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.


Neora Complexion Clearing 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 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.

  • BILBERRY (UNII: 9P2U39H18W)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
  • SACCHARUM OFFICINARUM WHOLE (UNII: 3Z20C92XNB)
  • ACER SACCHARUM SAP (UNII: 75UOH57984)
  • WATER (UNII: 059QF0KO0R)
  • WITCH HAZEL (UNII: 101I4J0U34)

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: Neora, Llc
Labeler Code: 72935
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: 05-01-2019 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: 12-31-2020 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.

Neora Complexion Clearing Product Label Images

Neora Complexion Clearing 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

Other

Drug Facts

Free from: Parabens • Synthetic Colorants • Synthetic Fragrance • Propylene Glycol
Distributed by:Neora, LLC, Dallas, TX 752441.855.463.7486www.neora.com

Otc - Active Ingredient

Active ingredientSalicylic acid 0.5%

Otc - Purpose

PurposeAcne treatment

Indications & Usage

Usefor the treatment of acne

Warnings

WarningsFor external use only.

Otc - When Using

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.

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

  • Directionscleanse the skin thoroughly before applying this product.apply pre-soaked pad to entire face or cover the entire affected area with a thin layer, one to three times daily.because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredient

Inactive ingredients Aloe barbadensis leaf juice, bilberry (Vaccinium myrtillus) fruit extract, caprylyl glycol, citric acid, disodium EDTA, disodium tetramethylhexadecenylcysteine formylprolinate, lauryl glucoside, lemon (Citrus limon) fruit extract, niacinamide, orange (Citrus aurantium dulcis) fruit extract, phenoxyethanol, PPG-5 ceteth-20, sodium hydroxide, sodium lauryl glucose carboxylate, sugar cane (Saccharum officinarum) extract, sugar maple (Acer saccharum) extract, water, witch hazel (Hamamelis virginiana) bark/leaf/twig extract.

* Please review the disclaimer below.

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