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| Product NDC Code | 10742-7011 | ||||
|---|---|---|---|---|---|
| Drug Name | Softlips pearl plus vanilla |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | part352 | ||||
| Labeler Name | The Mentholatum Company | ||||
| 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 ingredient Octinoxate 7.5% Octisalate 5%
Active Ingredient Dimethicone 2% Octinoxate 7.5% Octisalate 3% Oxybenzone 3%
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.Dosage and Administration apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor
Dosage and Administration apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecane copolymer, mineral oil, bis-diglycerl polyacyladipate-2, oleyl alcohol, copernicia cerifera (carnauba) wax, ricinus communis (castor) seed oil, cetyl lactate, polyethylene, paraffin, ammonium glycyrrhizate, BHT, flavor, magnesium stearate, menthol, tocopheryl acetate [vitamin E], bismuth oxychloride, carmine, mica, titanium dioxide
Inactive ingredients ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, flavor, menthol, tocopheryl acetate [vitamin E]
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
Uses helps prevent sunburn temporarily protects chapped or cracked lips
Purpose
Information about the drug product’s indications for use.Purpose Octinoxate – Sunscreen Octisalate - Sunscreen
Purpose Dimethicone – Skin protectant Octinoxate – Sunscreen Octisalate – Sunscreen Oxybenzone - Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Softlips Pearl Plus Vanilla dimethicone, octinoxate, octisalate, oxybenzone Softlips Pearl octinoxate, octisalate LANOLIN OIL HYDROGENATED POLYBUTENE (1300 MW) CERESIN MEADOWFOAM SEED OIL VINYLPYRROLIDONE/HEXADECENE COPOLYMER MINERAL OIL BIS-DIGLYCERYL POLYACYLADIPATE-2 OLEYL ALCOHOL CARNAUBA WAX CASTOR OIL CETYL LACTATE PARAFFIN AMMONIUM GLYCYRRHIZATE BUTYLATED HYDROXYTOLUENE MAGNESIUM STEARATE MENTHOL, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL BISMUTH OXYCHLORIDE CARMINIC ACID MICA TITANIUM DIOXIDE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE Softlips Vanilla dimethicone, octinoxate, octisalate, oxybenzone CERESIN SQUALANE ETHYLHEXYL PALMITATE PETROLATUM MYRISTYL MYRISTATE MYRISTYL LACTATE CETYL ALCOHOL MYRISTYL LAURATE MYRISTYL ALCOHOL BUTYLATED HYDROXYTOLUENE MENTHOL, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL DIMETHICONE DIMETHICONE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE
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 Front Blistercard
Principal Display Panel Back Blistercard
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.Softlips Pearl Drug Facts
Softlips Vanilla Drug Facts
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
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. 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? 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST) Softlips.com
Questions or comments? 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST) Softlips.com
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 condition worsens symptoms last more than 7 days or clear up and occur again within a few days
Stop use and ask a doctor if rash occurs condition worsens symptoms last more than 7 days or clear up and occur again within a few days
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.
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 protect this product from excessive heat and direct sun
Other information 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 Skin Cancer/Skin Agent Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only Do Not Use on damaged or broken skin When Using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings Skin Cancer/Skin Agent Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs condition worsens symptoms last more than 7 days or clear up and occur again within a few days 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