NDC 42681-0001 365 Medicated Lip Balm

Medicated Lip Balm

NDC Product Code 42681-0001

NDC 42681-0001-1

Package Description: 4.25 g in 1 TUBE

NDC Product Information

365 Medicated Lip Balm with NDC 42681-0001 is a a human over the counter drug product labeled by Whole Foods Market, Inc.. The generic name of 365 Medicated Lip Balm is medicated lip balm. The product's dosage form is stick and is administered via topical form.

Labeler Name: Whole Foods Market, Inc.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

365 Medicated Lip Balm 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.

  • CAMPHOR (NATURAL) .0578 g/4.25g

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.

  • COCONUT OIL (UNII: Q9L0O73W7L)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
  • MENTHOL (UNII: L7T10EIP3A)

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: Whole Foods Market, Inc.
Labeler Code: 42681
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 06-13-2019 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.

365 Medicated Lip Balm Product Label Images

365 Medicated Lip Balm 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

Otc - Active Ingredient

Active ingredient:Camphor 1.36%

Otc - Purpose

PurposeExternal Analgesic

Warnings

WarningsFor external use only. When using this product avoid contact with eyes. Stop useand ask a doctor if ■ Condition worsens ■ Symptoms last more than 7 days orclear up and occur again within a few days. Keep out of the reach of children.Do not use on: deep puncture wounds, serious burns, animal bites. If swallowed,get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Dosage & Administration

Directions■ Adults and children 2 years of age and older: Apply to lips notmore than 3 to 4 times daily ■ Children under 2 years of age: consult a doctor.

Other Safety Information

Other informationThis is a personal care item and should only be used by one individual only. Protect thisproduct from excessive heat and direct sun.

Inactive Ingredient

Inactive ingredients cocos nucifera (coconut) oil*, beeswax*,butyrospermum parkii (shea) butter*, helianthus annuus (sunflower) seed oil*, theobromacacao (cocoa) seed butter*, mentha arvensis leaf oil*, menthol*. *organic ingredient

Otc - Questions

Questions or comments?■ customer.questions@wholefoods.com■ 1-844-936-8255

Principal Display Package

NDC 42681-0001-1365EVERYDAY VALUEmedicatedLIP BALMSoothing Relief For Dry,Chapped LipsNET WT 0.15 OZ (4.25g)                FPO0 99482 48844 4DISTRIBUTED BY: WHOLE FOODS MARKET | 550 BOWIE STREET AUSTIN, TX 78703©2019 WHOLE FOODS MARKET IP, LPMADE IN USA FROM DOMESTIC AND IMPORTED INGREDIENTSSAFETYSEALrege

* Please review the disclaimer below.