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| Product NDC Code | 69740-309 | ||||
|---|---|---|---|---|---|
| Drug Name | Secura moisturizing cleanser |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | 505G(a)(3) | ||||
| 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 Benzethonium chloride 0.13%
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 cleanser liberally on affected area, then wipe clean no rinsing necessary
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS water, polysorbate 20, glycerin, polyquaternium-10, benzyl alcohol, fragrance, disodium EDTA, aloe barbadensis, FD&C Blue #1
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 antimicrobial skin cleanser for the perineum or body aids in the removal of urine and feces, or other foreign material
Purpose
Information about the drug product’s indications for use.PURPOSE Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Secura Moisturizing Cleanser BENZETHONIUM CHLORIDE POLYQUATERNIUM-10 (125 MPA.S AT 2%) BENZYL ALCOHOL FD&C BLUE NO. 1 ALOE VERA LEAF GLYCERIN POLYSORBATE 20 WATER EDETATE DISODIUM BENZETHONIUM CHLORIDE BENZETHONIUM Secura Moisturizing Cleanser BENZETHONIUM CHLORIDE ALOE VERA LEAF BENZYL ALCOHOL EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN POLYSORBATE 20 WATER BENZETHONIUM CHLORIDE BENZETHONIUM POLYQUATERNIUM-10 (125 MPA.S AT 2%)
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 MOISTURIZING CLEANSER (118mL) REF 59430800 NDC 69740-308-00 Moisturizing Cleanser Antimicrobial Skin Cleanser No-rinse, one-step cleansing for perineum or body Gently removes urine, feces, and other body fluids Reduces odor pH-balanced Pediatric-tested CHG compatible Smith&Nephew Secura ◊ Moisturizing Cleanser 4 fl. oz. (118 mL) Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road Hull, HU3 2BN, England www.smith-nephew.com ◊Trademark of Smith & Nephew. Certain marks reg’d in US Patent Office and Tm. Off. Package Display - Bottle, Spray (118mL)
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA MOISTURIZING CLEANSER (236mL) REF 59430900 NDC 69740-309-00 Moisturizing Cleanser Antimicrobial Skin Cleanser No-rinse, one-step cleansing for perineum or body Gently removes urine, feces, and other body fluids Reduces odor pH-balanced Pediatric-tested CHG compatible Smith&Nephew Secura ◊ Moisturizing Cleanser 8 fl. oz. (236 mL) Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road Hull, HU3 2BN, England www.smith-nephew.com ◊Trademark of Smith & Nephew. Certain marks reg’d in US Patent Office and Tm. Off. Package Display - Bottle, Spray (236mL)
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
QUESTION OR COMMENTS? 1 800 876-1261
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. If swallowed, get medical help or contact a Poison Control Center immediately
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.For external use only 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
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