NDC 0573-1945 Chapstick Flava Craze

Petrolatum

NDC Product Code 0573-1945

NDC CODE: 0573-1945

Proprietary Name: Chapstick Flava Craze 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: 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):
PURPLE (C48327)
BLUE (C48333)
PINK (C48328 - DARK PINK)
Shape: BULLET (C48335)
Size(s):
42 MM
Flavor(s):
GRAPE (C73391)
COTTON CANDY (C73382)
FRUIT PUNCH (C73390)

NDC Code Structure

  • 0573 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc

NDC 0573-1945-12

Package Description: 1 KIT in 1 KIT * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER

NDC Product Information

Chapstick Flava Craze with NDC 0573-1945 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Chapstick Flava Craze is 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)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SACCHARIN (UNII: FST467XS7D)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SACCHARIN (UNII: FST467XS7D)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SACCHARIN (UNII: FST467XS7D)
  • TRIACETIN (UNII: XHX3C3X673)
  • WHITE WAX (UNII: 7G1J5DA97F)

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: 07-14-2006 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 02-28-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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 Flava Craze 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 Ingredient

White petrolatum 44%

Purpose

Skin protectant

Uses

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

Warnings

For external use only

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.

Directions

Apply as needed

Other Information

Store at 20-25°C (68-77°F)

Inactive Ingredients

Arachidyl propionate, *artificial flavor, *benzyl alcohol, carnauba wax, cetyl alcohol, *red 6 lake, *blue 1 lake, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, methylparaben, *natural and artificial flavor, octyldodecanol, paraffin, phenyl trimethicone, propylparaben, saccharin, *triacetin, white wax *contains one or more of these ingredients

* Please review the disclaimer below.