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Softlips tropical coconut peach passion - Medication Information

Product NDC Code 10742-7005
Drug Name

Softlips tropical coconut peach passion

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 20 mg/g
Route TOPICAL
Dosage Form STICK
Application Number part347
Labeler Name The Mentholatum Company
Packages
Package NDC Code Description
10742-7005-1 2 tube in 1 blister pack (10742-7005-1) / 2 g in 1 tube
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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, cetyl alcohol, flavor, myristyl laurate, myristyl alcohol, ammonium glycyrrhizate, 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 Tropical Coconut Peach Passion dimethicone CERESIN PETROLATUM ETHYLHEXYL PALMITATE SQUALANE OCTYLDODECANOL MYRISTYL MYRISTATE CASTOR OIL MYRISTYL LACTATE CETYL ALCOHOL MYRISTYL LAURATE MYRISTYL ALCOHOL AMMONIUM GLYCYRRHIZATE BUTYLATED HYDROXYTOLUENE LEVOMENTHOL .ALPHA.-TOCOPHEROL ACETATE 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 Coconut Peach 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 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 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