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Product NDC Code | 78235-011 | ||||||||||||||||||
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Drug Name | Durashield original scent hand sanitizer |
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Type | Brand | ||||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||||
Dosage Form | LOTION | ||||||||||||||||||
RxCUI drug identifier | 1046442 | ||||||||||||||||||
Application Number | part333A | ||||||||||||||||||
Labeler Name | CK Polymers LLC | ||||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Active Ingredients: Benzalkonium 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 Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients water, corn starch, soybean oil, petrolatum, pectin, xanthan gum, citricidal, tributyl phosphate, methyl paraben, propyl paraben, vitamin E acetate, white linen fragrance
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.Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Purpose
Information about the drug product’s indications for use.Purpose Purpose: hand sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.DuraShield Original Scent Hand Sanitizer Safe and Silky Fragrance HS BENZALKONIUM CHLORIDE BENZALKONIUM WATER CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED SOYBEAN OIL PETROLATUM PECTIN XANTHAN GUM GRAPEFRUIT SEED OIL TRIBUTYL PHOSPHITE METHYLPARABEN PROPYLPARABEN ALPHA-TOCOPHEROL ACETATE BENZYL BENZOATE HEXAMETHYLINDANOPYRAN TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES .ALPHA.-ISOBUTYLPHENETHYL ALCOHOL BENZYL ACETATE METHYL-.ALPHA.-IONONE BENZYL SALICYLATE ISOMETHYL-.ALPHA.-IONONE BUTYLPHENYL METHYLPROPIONAL NEROL GERANIOL ISOAMYL SALICYLATE HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE CINNAMON LEAF OIL
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.55 Gallon Tote - DuraShield® Original Scent Hand Sanitizer - Label image description
330 Gallon Tote - DuraShield® Original Scent Hand Sanitizer - Label new-330
275 Gallon Tote - DuraShield® Original Scent - Label new-275
2OZ Bottle - DuraShield® Original Scent Hand Sanitizer - Label 2oz Durashield
4OZ Bottle - DuraShield® Original Scent Hand Sanitizer - Label 4 OZ Durashield
8OZ Bottle - DuraShield® Original Scent Hand Sanitizer - Label 8 oz Durashield
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.DuraShield® Original Scent Active Ingredients Active Ingredients: Benzalkonium chloride 0.13% Purpose Purpose: hand sanitizer Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Warnings For external use only. Do not use in children less than 2 months of age or an open skin wounds. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thouroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing. Other Information Store between 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (104°F) Inactive Ingredients water, corn starch, soybean oil, petrolatum, pectin, xanthan gum, citricidal, tributyl phosphate, methyl paraben, propyl paraben, vitamin E acetate, white linen fragrance
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store between 15-30°C (59-86°F) Avoid freezing and excessive heat above 40°C (104°F)
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. Do not use in children less than 2 months of age or an open skin wounds. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thouroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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