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Product NDC Code | 0573-0711 | ||||||
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Drug Name | Chapstick classic spearmint |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | STICK | ||||||
Application Number | M016 | ||||||
Labeler Name | Haleon US Holdings LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 Classic Spearmint white petrolatum PETROLATUM PETROLATUM ARACHIDYL PROPIONATE FD&C BLUE NO. 1 CARNAUBA WAX CETYL ALCOHOL ISOPROPYL MYRISTATE LANOLIN LIGHT MINERAL OIL MALTOL OCTYLDODECANOL PARAFFIN PHENYL TRIMETHICONE SACCHARIN WHITE WAX FD&C YELLOW NO. 5
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 BRAND LIP CARE ChapStick ® SKIN PROTECTANT CLASSIC SPEARMINT PROTECTS AND MOISTURIZES TO HELP HEAL DRY, CHAPPED LIPS NET WT 0.15 OZ (4 g) PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack
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.
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 Additional information Marketed by: Pfizer Madison, NJ 07940 USA ©2018 Pfizer Inc. For most recent product information, visit www.chapstick.com Paraben Free
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