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Chapstick - Medication Information

Product NDC Code 0573-2062
Drug Name

Chapstick

Type Brand
Dosage Form KIT
Application Number part347
Labeler Name GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Packages
Package NDC Code Description
0573-2062-01 1 kit in 1 package (0573-2062-01) * 4 g in 1 tube * 4 g in 1 tube * 4 g in 1 tube (0573-2061-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients White Petrolatum 45%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions apply as needed

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses • helps prevent and temporarily protects chafed, chapped or cracked lips • helps prevent and protect from the drying effects of wind and cold weather

Purpose

Information about the drug product’s indications for use.
Purpose Skin Protectant

Spl product data elements

Usually a list of ingredients in a drug product.
Chapstick White petrolatum Chapstick Mint Tea White petrolatum PETROLATUM PETROLATUM ARACHIDYL PROPIONATE FD&C BLUE NO. 1--ALUMINUM LAKE CARNAUBA WAX CETYL ALCOHOL ISOPROPYL MYRISTATE LANOLIN LIGHT MINERAL OIL MALTOL OCTYLDODECANOL PARAFFIN PHENYL TRIMETHICONE SACCHARIN WHITE WAX FD&C YELLOW NO. 5 ALUMINUM OXIDE Chapstick Rose Water PETROLATUM PARAFFIN MINERAL OIL OCTYLDODECANOL BIS-DIGLYCERYL POLYACYLADIPATE-2 MEDIUM-CHAIN TRIGLYCERIDES ARACHIDYL PROPIONATE PHENYL TRIMETHICONE CARNAUBA WAX ISOPROPYL MYRISTATE CETYL ALCOHOL LECITHIN, SOYBEAN SACCHARIN LANOLIN TITANIUM DIOXIDE D&C RED NO. 6 ALUMINUM OXIDE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 Chapstick Almond Oil PETROLATUM PARAFFIN MINERAL OIL OCTYLDODECANOL CANOLA OIL BIS-DIGLYCERYL POLYACYLADIPATE-2 ARACHIDYL PROPIONATE PHENYL TRIMETHICONE CARNAUBA WAX ISOPROPYL MYRISTATE CETYL ALCOHOL LECITHIN, SOYBEAN TITANIUM DIOXIDE SYNTHETIC WAX (1200 MW) SACCHARIN FERROUS OXIDE ISOPROPYL TITANIUM TRIISOSTEARATE FD&C YELLOW NO. 6 ALUMINUM OXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel 0573-2062-01 ChapStick ® SPA Collection a refreshing flavor experience for lips 1 Skin Protectant 2 Cosmetics ·3 Sticks NET WT 0.15 OZ (4 g) EACH PAA159505 Chapstick Spa Collection 0.15oz (4 g)

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
ChapStick Mint Tea 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) 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 Questions or comments? Call weekdays from 9 AM to 5 PM EST at 1-877-227-3421 ChapStick Rose Water 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 Other information store at 20-25°C (68-77°F) Chapstick Almond Oil Ingredients 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 Other information store at 20-25°C (68-77°F) Additional information Paraben-Free Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 For most recent product information, visit www.chapstick.com Trademarks owned or licensed by GSK ©2020 GSK or licensor

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information store at 20-25°C (68-77°F) Other information store at 20-25°C (68-77°F)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20-25°C (68-77°F)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API