NDC 0573-2062 Chapstick

White Petrolatum

NDC Product Code 0573-2062

NDC CODE: 0573-2062

Proprietary Name: Chapstick What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: White Petrolatum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
GREEN (C48329)
Flavor(s):
SPEARMINT (C73416)

NDC Code Structure

  • 0573 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc

NDC 0573-2062-01

Package Description: 1 KIT in 1 PACKAGE * 4 g in 1 TUBE * 4 g in 1 TUBE * 4 g in 1 TUBE (0573-2061-01)

NDC Product Information

Chapstick with NDC 0573-2062 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Chapstick is white petrolatum. The product's dosage form is kit and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
  • FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • MALTOL (UNII: 3A9RD92BS4)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • SACCHARIN (UNII: FST467XS7D)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • ALUMINUM OXIDE (UNII: LMI26O6933)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0573
FDA Application Number: part347 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: 03-28-2021 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.

Chapstick 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

White Petrolatum 45%

Purpose

Skin Protectant

Uses

  • •helps prevent and temporarily protects chafed, chapped or cracked lips •helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

Keep Out Of Reach Of Children

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

Directions

Apply as needed

Other Information

Store at 20-25°C (68-77°F)

Store at 20-25°C (68-77°F)

Store at 20-25°C (68-77°F)

Inactive Ingredients

Arachidyl propionate, blue 1 lake, carnauba wax, cetyl alcohol, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, maltol, natural and artificial flavor, octyldodecanol, paraffin, phenyl trimethicone, saccharin, white wax, yellow 5 lake

Ingredients

Petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), flavor, saccharin, lanolin, titanium dioxide, red 6 lake, yellow 6 lake, yellow 10 lake

Petrolatum, paraffin, mineral oil, octyldodecanol, canola oil, bis-diglyceryl polyacyladipate-2, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), titanium dioxide, synthetic wax, flavor, saccharin, iron oxides, isopropyl titanium trisostearate, yellow 6 lake

Additional Information

Paraben-FreeDistributed by: GSK Consumer Healthcare, Warren, NJ 07059For most recent product information, visit www.chapstick.comTrademarks owned or licensed by GSK©2020 GSK or licensor

* Please review the disclaimer below.