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Product NDC Code | 68828-010 | ||||
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Drug Name | Jafra fruteria coco fresco lip balm |
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Type | Brand | ||||
Pharm Class | Skin Barrier Activity [PE] | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | part347 | ||||
Labeler Name | Jafra Cosmetics International, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Dimethicone 1%
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 Polybutene, Bis-Diglyceryl Polyacyladipate-2, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Prunus Armeniaca (Apricot) Kernel Oil, Ozokerite, Garcinia Indica Seed Butter, Persea Gratissima (Avocado) Oil, Flavor/Aroma, Silica Dimethyl Silylate, Oleic / Linoleic / Linolenic Polyglycerides, Dimethicone, Pouteria Sapota Seed Oil, Tocopheryl Acetate, Benzyl Alcohol, Limonene.
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 and helps relieve 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 Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.JAFRA Fruteria Coco Fresco Lip Balm DIMETHICONE POLYBUTENE (1400 MW) BIS-DIGLYCERYL POLYACYLADIPATE-2 SESAME OIL SHEA BUTTER APRICOT KERNEL OIL CERESIN GARCINIA INDICA SEED BUTTER AVOCADO OIL SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL ACETATE BENZYL ALCOHOL LIMONENE, (+)- 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.Product label image description
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 in 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