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| Product NDC Code | 69740-315 | ||||
|---|---|---|---|---|---|
| Drug Name | Secura protective |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 581802 | ||||
| Application Number | M016 | ||||
| Labeler Name | Smith & Nephew Medical Ltd | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Petrolatum 98.849%
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 change wet and soiled diapers, garments and linens promptly cleanse the affected area and allow to dry apply ointment liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS benzyl alcohol, clove oil, tocopheryl acetate, butylparaben, corn oil, retinyl palmitate, cholecalciferold, D&C Green #6
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 Skin protectant Helps treat and prevent diaper dermatitis Protects minor skin irritation associated with diaper dermatitis and helps seal out wetness
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.Secura Protective petrolatum BUTYLPARABEN BENZYL ALCOHOL CLOVE OIL D&C GREEN NO. 6 ALPHA-TOCOPHEROL ACETATE CHOLECALCIFEROL VITAMIN A PALMITATE CORN OIL PETROLATUM PETROLATUM Secura Protective petrolatum BUTYLPARABEN BENZYL ALCOHOL CLOVE OIL D&C GREEN NO. 6 ALPHA-TOCOPHEROL ACETATE CHOLECALCIFEROL VITAMIN A PALMITATE CORN OIL PETROLATUM PETROLATUM
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.PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (70g) #59431500 NDC -69740-315-00 Protective Ointment Skin Protectant For treatment and prevention of incontinence-associated dermatitis Enriched with Vitamins A, D & E Pediatric tested CHG compatible Enriched with Clove Oil Smith&Nephew Secura Protective Ointment Net wt. 2.47 oz (70 g) Made in India for: Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England Trademark of Smith & Nephew. Certain marks Reg'd U.S. Pat. & Tm. Off. 69740-315
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (159g) #59431600 NDC-69740-316-00 Protective Ointment Skin Protectant For treatment and prevention of incontinence-associated dermatitis Enriched with Vitamins A, D & E Pediatric tested CHG compatible Enriched with Clove Oil Smith&Nephew Secura Protective Ointment Net wt. 5.6 oz (159 g) Made in India for: Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England Trademark of Smith & Nephew. Certain marks Reg'd U.S. Pat. & Tm. Off. 69740-316
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
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 immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS? 1 800 876-1261
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 Avoid contact with the eyes Not to be applied over deep or puncture wounds, infections or lacerations If condition worsens or does not improve within 7 days, contact a doctor
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