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| Product NDC Code | 69740-312 | ||||
|---|---|---|---|---|---|
| Drug Name | Secura protective |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 248279 | ||||
| Application Number | M005 | ||||
| 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 INGREDIENT Zinc oxide 10%
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 cream 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 water, petrolatum, cetearyl alcohol, PEG-40 castor oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, propylparaben, aloe barbadensis
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 ZINC OXIDE ALOE VERA LEAF PROPYLPARABEN POLYSORBATE 20 OCTYL STEARATE WATER ALLANTOIN CLOVE OIL METHYLPARABEN SODIUM CETOSTEARYL SULFATE ALPHA-TOCOPHEROL ACETATE PETROLATUM CETOSTEARYL ALCOHOL POLYOXYL 40 CASTOR OIL ZINC OXIDE ZINC CATION OCTYL PALMITATE DIOCTYL ADIPATE Secura Protective ZINC OXIDE ALOE VERA LEAF PEG-40 CASTOR OIL PROPYLPARABEN ALLANTOIN SODIUM CETOSTEARYL SULFATE CLOVE OIL METHYLPARABEN POLYSORBATE 20 WATER ALPHA-TOCOPHEROL ACETATE PETROLATUM CETOSTEARYL ALCOHOL DIOCTYL ADIPATE OCTYL PALMITATE ZINC OXIDE ZINC OXIDE OCTYL STEARATE
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- TUBE (50g) REF 59431100 NDC 69740-311-00 Protective Cream Skin Protectant For treatment and prevention of incontinence-asssociated dermatitis Pediatric tested CHG compatible Enriched with Allantoin, Vitamin E and Aloe Clove Oil controls odor Conditions and soothes Smith & Nephew Secura ◊ Protective Cream Made in India for: Smith & Nephew Medical Ltd, 101 Hessle Road Hull, HU3 2BN, England www.smith-nephew.com ◊Trademark of Smith & Nephew Certain markes reg’d US Pat. And Tm Off. 59431100
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (78g) REF 59431200 NDC 69740-312-00 Protective Cream Skin Protectant For treatment and prevention of incontinence-asssociated dermatitis Pediatric tested CHG compatible Enriched with Allantoin, Vitamin E and Aloe Clove Oil controls odor Conditions and soothes Smith & Nephew Secura ◊ Protective Cream Made in India for: Smith & Nephew Medical Ltd, 101 Hessle Road Hull, HU3 2BN, England www.smith-nephew.com ◊Trademark of Smith & Nephew Certain markes reg’d US Pat. And Tm Off. 59431200
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Not to be applied over deep or puncture wounds, infections or lacerations
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 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.QUESTION OR COMMENTS? 1 800 876-1261
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.If condition worsens or does not improve within 7 days, contact a doctor
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.Avoid contact with 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 Avoid contact with 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately Avoid contact with 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 KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
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