Secura Protective
Zinc Oxide
Smith & Nephew Medical Ltd
Human Otc Drug
NDC 69740-311Secura Protective also known as Zinc Oxide is a human otc drug labeled by 'Smith & Nephew Medical Ltd'. National Drug Code (NDC) number for Secura Protective is 69740-311. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Secura Protective drug includes Zinc Oxide - 100 mg/g . The currest status of Secura Protective drug is Active.
Drug Information:
| Drug NDC: | 69740-311 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Secura Protective |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Smith & Nephew Medical Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ZINC OXIDE - 100 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Aug, 2003 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part347 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Smith & Nephew Medical Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 248279
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | SOI2LOH54Z
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69740-311-00 | 50 g in 1 TUBE (69740-311-00) | 01 Aug, 2003 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose skin protectant
Product Elements:
Secura protective zinc oxide zinc oxide zinc cation water allantoin clove oil methylparaben polysorbate 20 sodium cetostearyl sulfate alpha-tocopherol acetate petrolatum aloe vera flower cetostearyl alcohol polyoxyl 40 castor oil ethylhexyl palmitate secura protective zinc oxide zinc oxide zinc oxide allantoin aloe sodium cetostearyl sulfate clove oil methylparaben polysorbate 20 water alpha-tocopherol acetate petrolatum cetostearyl alcohol polyoxyl 40 castor oil ethylhexyl palmitate
Indications and Usage:
Uses skin protectant helps treat and prevent diaper dermatitis protects minor skin irritation associated with diaper dermatitis and helps seal out wetness
Warnings:
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
Do Not Use:
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
When Using:
Avoid contact with eyes
Dosage and Administration:
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
Stop Use:
If condition worsens or does not improve within 7 days, contact a doctor
Package Label Principal Display Panel:
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 â protective cream made in india for: smith & nephew medical ltd, 101 hessle road hull, hu3 2bn, england www.smith-nephew.com âtrademark of smith & nephew certain markes regâd us pat. and tm off. package display - tube (50g)
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 â protective cream made in india for: smith & nephew medical ltd, 101 hessle road hull, hu3 2bn, england www.smith-nephew.com âtrademark of smith & nephew certain markes regâd us pat. and tm off. package display - tube (78g)
Further Questions:
Question or comments? 1 800 876-1261