NDC 26052-039 Nas Purifying Cleanser

Salicylic Acid

NDC Product Code 26052-039

NDC 26052-039-01

Package Description: 145 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Nas Purifying Cleanser with NDC 26052-039 is a a human over the counter drug product labeled by Burt's Bees, Inc.. The generic name of Nas Purifying Cleanser is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Burt's Bees, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Nas Purifying Cleanser 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 1 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.

  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • SALIX NIGRA BARK (UNII: QU52J3A5B3)
  • WATER (UNII: 059QF0KO0R)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • SUCROSE LAURATE (UNII: 05Q7CD0E49)
  • COCO-BETAINE (UNII: 03DH2IZ3FY)
  • BETAINE (UNII: 3SCV180C9W)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)
  • HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALCOHOL (UNII: 3K9958V90M)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • LONICERA CAPRIFOLIUM FLOWERING TOP (UNII: 1X0T378SXY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • LONICERA JAPONICA TOP (UNII: 60Q6UP226V)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)

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: Burt's Bees, Inc.
Labeler Code: 26052
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: 03-01-2021 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".

* Please review the disclaimer below.

Nas Purifying Cleanser 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 1.0%

Purpose

ACNE TREATMENT

Uses

• For the treatment of acne • Clears and helps prevent acne blemishes, pimples, blackheads and whiteheads

Warnings

For external use only. • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only one medication should be used unless directed by a doctor.

Keep Out Of Reach Of Children

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control

Center right away.

Directions

• To cleanse, cover entire area with a thin layer one to three times a day, rinse thoroughly • Avoid the eye area, if contact occurs rinse thoroughly with water • Because excessive dryness may occur, start with one application daily, then 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

Questions?

800-849-7112 OR
WWW.BURTSBEES.COM

Inactive Ingredients

Water, lauryl glucoside, decyl glucoside, sucrose laurate, salix nigra (willow) bark extract, sodium chloride, coco-betaine, betaine, centella asiatica leaf extract, coco-glucoside, glycerin, glyceryl oleate, lonicera japonica (honeysuckle) flower extract, lonicera caprifolium (honeysuckle) flower extract, potassium cocoyl hydrolyzed soy protein, citric acid, hydrogenated palm glycerides citrate, lecithin, alcohol, tocopherol, ascorbyl palmitate, sodium phytate, fragrance*, sodium benzoate, phenoxyethanol

* Please review the disclaimer below.