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| Product NDC Code | 33992-0498 | ||||
|---|---|---|---|---|---|
| Drug Name | Petrolatum |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1043075 | ||||
| Application Number | part347 | ||||
| Labeler Name | Greenbrier International, 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: White Petrolatum USP (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), glycerin, glyceryl monostearate, PEG-100 stearate, stearic acid, ceteareth 20, trieathanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA 110781 DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 MADE IN INDIA Skin Softener Hydrates & Evens Skin Tone COCOA BUTTER Petroleum Jelly C. No. DNH/COS/DNH/130 1222101976
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.Petrolatum Petrolatum Petrolatum Petrolatum Water GLYCERIN GLYCERYL MONOSTEARATE PEG-100 STEARATE STEARIC ACID POLYOXYL 20 CETOSTEARYL ETHER TROLAMINE LANOLIN ALCOHOLS CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) PHENOXYETHANOL TRIETHYLENE GLYCOL COCOA BUTTER .ALPHA.-TOCOPHEROL ACETATE EDETATE DISODIUM
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 oz Tube Label ASSURED™ Vitamin E Enriched Creamy COCOA BUTTER Petroleum Jelly Skin Softener Hydrates & Evens Skin Tone Net Wt 3 oz (85g) NDC # 33992-0498-1 Principal Display Panel - 3 oz Tube Label
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 doctor if condition worsens, symptoms last more than 7 days 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. Do not use on deep puncture wounds, animal bites and 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 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