NDC 26052-041 Nas Targeted Spot Treatment

Salicylic Acid

NDC Product Code 26052-041

NDC 26052-041-02

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 7.5 g in 1 BOTTLE, WITH APPLICATOR (26052-041-01)

NDC Product Information

Nas Targeted Spot Treatment with NDC 26052-041 is a a human over the counter drug product labeled by Burt's Bees. The generic name of Nas Targeted Spot Treatment is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Burt's Bees

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 Targeted Spot 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 .75 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • FENNEL OIL (UNII: 59AAO5F6HT)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • LEMON OIL (UNII: I9GRO824LL)
  • BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
  • PARSLEY OIL (UNII: IXK9N7RJ7J)
  • SALIX NIGRA BARK (UNII: QU52J3A5B3)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • JUNIPER BERRY OIL (UNII: SZH16H44UY)
  • ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

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
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 Targeted Spot 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

Otc - Active Ingredient

Salicylic Acid 0.75%

Otc - Purpose

Acne Treatment

Uses

  • For the treatment of acne. Clearsacne blemishes, acne 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.

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.

Keep Out Of Reach Of Children

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

Directions

• Clean the skin thoroughly before applying the product, Cover the blemish with a thin layer one to three times a day • 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

Inactive Ingredient

Inactive Ingredients: alcohol denat., citrus limon (lemon) peel oil, water,achillea millefolium extract, borago officinalis extract, calendula officinalis flower extract, carum petroselinum (parsley) extract, foeniculum vulgare (fennel) oil, salix nigra (willow) bark extract, glycerin, melaleuca alternifolia (tea tree) leaf oil, centella asiatica leaf extract, eucalyptus globulus leaf oil, juniperus communis fruit oil

Otc - Questions

Questions? 800-849-7112 or www.burtsbees.com

* Please review the disclaimer below.