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Product NDC Code | 52000-124 | ||||
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Drug Name | Cocoa butter petroleum jelly |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 1037285 | ||||
Application Number | part347 | ||||
Labeler Name | Universal Distribution Center LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient: Petrolatum 30%
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: water (aqua), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, stearyl alcohol, glyceryl stearate, fragrance, polysorbate 80, laureth-20, BHT, methylparaben, propylparaben, dimethicone, tocopherol.
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 minor: • cuts • scrapes • burns • temporarily protects and helps relieve chapped or cracked skin • helps 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.COCOA BUTTER PETROLEUM jelly Petrolatum PETROLATUM PETROLATUM WATER MINERAL OIL GLYCERIN CETOSTEARYL ALCOHOL CETYL ALCOHOL STEARYL ALCOHOL GLYCERYL MONOSTEARATE POLYSORBATE 80 LAURETH-20 BUTYLATED HYDROXYTOLUENE METHYLPARABEN PROPYLPARABEN DIMETHICONE TOCOPHEROL
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.Packaging IMAGE
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
New Vitamin E Moisturizing with Cocoa Butter Extra Rich Compare to the active ingredient of Vaseline ® Petroleum Jelly Cream* Tones, softens & smooths dry skin Distributed by: Universal Distribution Center 96 Distribution Boulevard Edison, NJ 08817 www.universaldc.com Made in P.R.C
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.
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. Do not use on • deep puncture wounds • animal bites • serious burns 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