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| Product NDC Code | 10742-7003 | ||||
|---|---|---|---|---|---|
| Drug Name | Softlips watermelon, tropical coconut, peach passion |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | part347 | ||||
| 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 ingredients Dimethicone 2%
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 ozokerite, petrolatum, ethylhexyl palmitate, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetatate [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 and temporarily protects 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 Dimethicone - Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Softlips Watermelon, Tropical Coconut, Peach Passion dimethicone CERESIN PETROLATUM ETHYLHEXYL PALMITATE SQUALANE OCTYLDODECANOL MYRISTYL MYRISTATE CASTOR OIL MYRISTYL LACTATE CETYL ALCOHOL MYRISTYL LAURATE MYRISTYL ALCOHOL BUTYLATED HYDROXYTOLUENE MENTHOL, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL DIMETHICONE DIMETHICONE
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.Package/Label Principal Display Panel Softlips Lip Protectant: Watermelon, Tropical Coconut, Peach Passion
Package/Label Principal Display Panel Drug Facts
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? 1-877-636-2677 MON-FRI 9AM to 5PM (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 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 do not get into eyes
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 When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
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