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| Product NDC Code | 10157-1189 | ||||
|---|---|---|---|---|---|
| Drug Name | Repair and protect |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | part347 | ||||
| Labeler Name | Blistex Inc. | ||||
| 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 Petrolatum 45.0% (w/w)
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 beeswax, butylene glycol, butyrospermum parkii (shea) butter, chamomilla recutita (matricaria) flower extract, ethylhexyl palmitate, helianthus annuus (sunflower) seed oil, lanolin, microcrystalline wax, octyldodecanol, ozokerite, paraffin, persea gratissima (avocado) oil, phenoxyethanol, phenyl trimethicone, silica dimethyl silylate, simmondsia chinensis (jojoba) seed oil, sodium hyaluronate, tocopheryl acetate
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 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 Lip protectant
Spl product data elements
Usually a list of ingredients in a drug product.Repair and Protect Petrolatum PETROLATUM PETROLATUM CERESIN LANOLIN MICROCRYSTALLINE WAX OCTYLDODECANOL PHENYL TRIMETHICONE YELLOW WAX SUNFLOWER OIL CHAMOMILE ETHYLHEXYL PALMITATE SILICA DIMETHYL SILYLATE BUTYLENE GLYCOL HYALURONATE SODIUM AVOCADO OIL JOJOBA OIL SHEA BUTTER .ALPHA.-TOCOPHEROL ACETATE PARAFFIN PHENOXYETHANOL
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 - 3.69 g Cylinder Blister Pack Blistex ® NEW Lip Protectant DERMATOLOGIST RECOMMENDED* REPAIR & PROTECT Relieves and Protects Severely Dry, Chapped Lips Smooth Formula for Long-Lasting Moisture Net Wt. 0.13 oz. (3.69 g) PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack
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.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 deep or puncture wounds animal bites serious burns
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.
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
Storage and handling
Information about safe storage and handling of the drug product.Other information protect the product in this container 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 For external use only Do not use on deep or puncture wounds animal bites serious burns 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 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