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| Product NDC Code | 0573-0768 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Chapstick moisturizer cool mint |
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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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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 3% Octinoxate 7.5% White petrolatum 41.4%
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 liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • children under 6 months of age: Ask a doctor • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: o limited time in the sun, especially from 10 a.m. – 2 p.m. o wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf extract, artificial flavor, carnauba wax, cetyl alcohol, isocetyl stearate, isopropyl lanolate, lanolin, medium-chain triglycerides, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax
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 sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun • 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.Purposes Sunscreens Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Chapstick Moisturizer Cool Mint avobenzone, octinoxate, and white petrolatum AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE PETROLATUM PETROLATUM ALOE VERA LEAF CARNAUBA WAX CETYL ALCOHOL .ALPHA.-TOCOPHEROL LINOLEATE, D- ISOCETYL STEARATE LANOLIN MEDIUM-CHAIN TRIGLYCERIDES MINERAL OIL PARAFFIN SACCHARIN .ALPHA.-TOCOPHEROL ACETATE WHITE WAX
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 NEW Improved Formula BRAND LIP CARE ChapStick ® SKIN PROTECTANT | SUNSCREEN BROAD SPECTRUM SPF 15 MOISTURIZER 2 in 1 Lipcare 8 HOUR MOISTURE SPF 15 Cool Mint NET WT 0.15 OZ (4 g) Principal Display Panel - 4 g Cylinder Blister Pack
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin
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
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at 20-25°C (68-77°F) • protect this product from excessive heat and direct sun
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 Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. 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