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| Product NDC Code | 0573-2027 | ||||
|---|---|---|---|---|---|
| Drug Name | Chapstick |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| 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 42.3%
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 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: limited time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Directions Apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf extract, carnauba wax, cetyl alcohol, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax
Inactive ingredients (Original) arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium, white wax, yellow 5 lake
Inactive ingredients (Cherry) arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax
Inactive ingredients (Strawberry) arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, 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
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.Purposes Sunscreens Skin protectant
Purpose Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Chapstick avobenzone, octinoxate, and white petrolatum ChapStick Moisturizer Original avobenzone, octinoxate, and white petrolatum ALOE VERA LEAF CARNAUBA WAX CETYL ALCOHOL .ALPHA.-TOCOPHEROL LINOLEATE, D- ISOCETYL STEARATE LANOLIN MINERAL OIL PARAFFIN SACCHARIN .ALPHA.-TOCOPHEROL ACETATE WHITE WAX AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE PETROLATUM PETROLATUM ChapStick Classic Strawberry white petrolatum ARACHIDYL PROPIONATE CAMPHOR (NATURAL) CARNAUBA WAX CETYL ALCOHOL ISOPROPYL MYRISTATE LANOLIN LEMON OIL, COLD PRESSED LIGHT MINERAL OIL MALTOL OCTYLDODECANOL PARAFFIN PHENYL TRIMETHICONE D&C RED NO. 6 SACCHARIN WHITE WAX PETROLATUM PETROLATUM ChapStick Classic Cherry white petrolatum ARACHIDYL PROPIONATE CAMPHOR (NATURAL) CARNAUBA WAX CETYL ALCOHOL ISOPROPYL MYRISTATE LANOLIN LIGHT MINERAL OIL LEVOMENTHOL OCTYLDODECANOL PARAFFIN PHENYL TRIMETHICONE D&C RED NO. 6 SACCHARIN WHITE WAX PETROLATUM PETROLATUM ChapStick Classic Original white petrolatum ARACHIDYL PROPIONATE CAMPHOR (NATURAL) CARNAUBA WAX CETYL ALCOHOL ISOPROPYL MYRISTATE LANOLIN LIGHT MINERAL OIL OCTYLDODECANOL OLEYL ALCOHOL PARAFFIN PHENYL TRIMETHICONE D&C RED NO. 6 TITANIUM DIOXIDE WHITE WAX FD&C YELLOW NO. 5 PETROLATUM PETROLATUM ChapStick total hydration Eucalyptus Mint ChapStick total hydration Soothing Vanilla
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 NDC 0573-2027-01 ChapStick ® PUT YOUR LIPS FIRST® 1 EUCALYPTUS MINT 1 SOOTHING VANILLA *100% naturally sourced ingredients Age defying formula with argan oil and avocado butters Contains omegas 6 & 9 2 MOISTURIZER ORIGINAL SKIN PROTECTANT / SUNSCREEN BROAD SPECTRUM SPF 15 SPF 15 2 CLASSIC STRAWBERRY SKIN PROTECTANT 3 CLASSIC CHERRY SKIN PROTECTANT Paraben Free Cruelty Free 3 CLASSIC ORIGINAL SKIN PROTECTANT 12 INDIVIDUAL STICKS TOTAL HYDRATION -2 STICKS NET WT 0.12 OZ (3.5g) EACH MOISTURIZER -2 STICKS NET WT 0.15 OZ (4g) EACH CLASSIC -8 STICKS NET WT 0.15 OZ (4g) EACH PAA166168 – Front PAA166168 Chapstick 12 Individual Sticks
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.Moisturizer 2 in 1 Lip Care | Original Active ingredients Avobenzone 3% Octinoxate 7.5% White petrolatum 42.3% Purposes Sunscreens Skin protectant 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 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. 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: limited time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Other Information store at 20-25°C (68-77°F) protect this product from excessive heat and direct sun Inactive ingredients aloe barbadensis leaf extract, carnauba wax, cetyl alcohol, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax Questions or Comments? call weekdays from 9 AM to 5 PM EST at 1-877-227-3421
Classic | Original . Cherry . Strawberry Active ingredient 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 Directions Apply as needed Other Information store at 20-25°C (68-77°F) Inactive ingredients (Original) arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium, white wax, yellow 5 lake Inactive ingredients (Cherry) arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax Inactive ingredients (Strawberry) arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax
Chapstick total hydration Eucalyptus Mint Ingredients: helianthus annuus (sunflower) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, cocos nucifera (coconut) oil, beeswax, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax, argania spinosa (argan) kernel oil, flavor, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, mangifera indica (mango) seed butter, butyrospermum parkii (shea) butter, octyldodecanol, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, tocopherol, hydrogenated soybean oil, aloe barbadensis leaf extract, rubus idaeus (raspberry) seed oil, glyceryl stearate Other information store at 20-25°C (68-77°F).
Chapstick total hydration Soothing Vanilla Ingredients: helianthus annuus (sunflower) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, cocos nucifera (coconut) oil, beeswax, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax, argania spinosa (argan) kernel oil, flavor, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, mangifera indica (mango) seed butter, butyrospermum parkii (shea) butter, octyldodecanol, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, tocopherol, hydrogenated soybean oil, aloe barbadensis leaf extract, rubus idaeus (raspberry) seed oil, glyceryl stearate Other information store at 20-25°C (68-77°F).
Additional Information Paraben Free . Cruelty Free Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 For most recent product information, visit www.chapstick.com Trademarks owned or licensed by GSK ©2021 GSK or licensor Patents: www.productspats.com
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.
Keep Out of Reach of Children
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
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
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 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.
Warnings For external use only Keep Out of Reach of Children
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