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| Product NDC Code | 51514-0363 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Barrier balm |
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| Type | Generic | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OINTMENT | ||||||||
| RxCUI drug identifier | 2665902 | ||||||||
| Application Number | M016 | ||||||||
| Labeler Name | Autumn Harp, 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 41.9% Dimethicone 13.0%
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.Apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Caprylic/Capric triglyceride, Butyrospermum Parkii (Shea Butter), Aluminum Starch Octenylsuccinate, Synthetic Wax, Polyhydroxystearic Acid, Sodium Hyaluronate, Water, Zinc Oxide, Tocopheryl Acetate, Triethoxycaprylylsilane
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.Directions Apply as needed
Purpose
Information about the drug product’s indications for use.Helps prevent, temporarily protects and helps relieve chafed, chapped or cracked skin Helps prevent and protect from the drying effects of wind and cold weather Temporarily protects minor cuts, scrapes, burns
Spl product data elements
Usually a list of ingredients in a drug product.Barrier Balm Barrier Balm POLYHYDROXYSTEARIC ACID (2300 MW) ZINC OXIDE .ALPHA.-TOCOPHEROL ACETATE, DL- DIMETHICONE 20 DIMETHICONE 20 SYNTHETIC WAX (1800 MW) WATER BUTYLATED HYDROXYTOLUENE PETROLATUM PETROLATUM MEDIUM-CHAIN TRIGLYCERIDES SHEA BUTTER ALUMINUM STARCH OCTENYLSUCCINATE TRIETHOXYCAPRYLYLSILANE HYALURONATE SODIUM
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.48g tube carton artwork 15g carton artwork with drug facts box 28g carton artwork with drug facts box 15g tube primary container image 28g tube primary artwork image 48g tube primary artwork image
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? 858-859-1188
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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away 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 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