NDC 26052-040 Nas Pore Refining Scrub

Salicylic Acid

NDC Product Code 26052-040

NDC 26052-040-01

Package Description: 110 g in 1 TUBE

NDC Product Information

Nas Pore Refining Scrub with NDC 26052-040 is a a human over the counter drug product labeled by Burt's Bees, Inc.. The generic name of Nas Pore Refining Scrub is salicylic acid. The product's dosage form is emulsion and is administered via topical form.

Labeler Name: Burt's Bees, Inc.

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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 Pore Refining 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 1 g/100g

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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ALCOHOL (UNII: 3K9958V90M)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • PULLULAN (UNII: 8ZQ0AYU1TT)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SALIX NIGRA BARK (UNII: QU52J3A5B3)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)

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 Pore Refining 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 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.

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

Directions

• Cover entire area with a thin layer one to two times a day, massage gently and 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 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 Ingredients

Water, helianthus annuus (sunflower) seed oil, glycerin, caprylic/capric triglyceride, cocos nucifera (coconut) oil, glyceryl stearate citrate, stearic acid, salix nigra (willow) bark extract, copernicia cerifera (carnauba) wax, butyrospermum parkii (shea) butter, centella asiatica leaf extract, xanthan gum, lecithin, sclerotium gum, pullulan, silica, tocopherol, glycine soja (soybean) oil, citric acid,

alcohol, fragrance*, sodium phytate, phenoxyethanol

Questions?

800-849-7112 OR
WWW.BURTSBEES.COM

Pdp

NATURAL ACNE SOLUTIONSDEEP CLEANSINGScrubsalicyclic acid acne treatmentwith soothing cica99% NATURAL ORIGINNet Wt. 4 oz / 113 g

* Please review the disclaimer below.