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Product NDC Code | 58980-350 | ||||
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Drug Name | White petrolatum |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 204754 | ||||
Application Number | part347 | ||||
Labeler Name | STRATUS PHARMACEUTICALS INC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient White Petrolatum USP 100%
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 Cleanse area with mild soap and water. Apply White Petrolatum liberally generously to affected area.
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.Indications For the temporary protection of minor cuts, scrapes, abrasions, burns, sunburns, chafed or chapped skin. Helps treat and prevent diaper rash. Caution In case of deep or puncture wounds or severe burns, consult a physician. If irritation, swelling or pain persists, or if infection occurs, discontinue use and consult a physician. For external use only.
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.WHITE PETROLATUM PETROLATUM PETROLATUM PETROLATUM OFF WHITE
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 - 5 g Packet Box NDC: 58980-350-50 White Petrolatum USP Ointment Skin Protectant Smooths skin irritations due to: ▪ minor burns ▪ scrapes ▪ abrasions STRATUS PHARMACEUTICALS INC Contains: 144 packets / 5g each PRINCIPAL DISPLAY PANEL - 5 g Packet Box
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:
Description White Petrolatum USP is a first aid ointment that protects and revitalizes chapped and cracked skin areas. It contains 100% White Petrolatum USP to help seal moisture into the skin. White Petrolatum USP Ointment can be applied to minor skin injuries including cuts, scrapes, rashes and burns. Each pouch contains a 5g unit dose individually sealed and barcoded.
Distributed by: Stratus Pharmaceuticals Inc., Miami, FL 33186
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Toll Free: 1-800-442-7882
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat.
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 Do not use in the eyes. If swallowed, get medical help or contact a Poison Control Center immediately. Keep out of reach of children.
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