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Product NDC Code | 11822-0283 | ||||
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Drug Name | Simplify antibacterial hand wipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
RxCUI drug identifier | 1038558 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Rite Aid Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient 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 wipe hands thoroughly with product and allow to dry for children under 6, use only under adult supervision not recommended for infants
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients water (aqua), glycerin, sodium benzoate, potassium sorbate, aloe barabadensis leaf juice, fragrance (parfum), caprylyl/capryl glucoside, polyglyceryl-4 laurate/sebacate, polyglyceryl-6 caprylate/caprate, citric acid, polysorbate 20
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 to decrease bacteria on the skin
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Simplify Antibacterial Hand Wipes Benzalkonium chloride POLYSORBATE 20 CAPRYLYL/CAPRYL OLIGOGLUCOSIDE ANHYDROUS CITRIC ACID BENZALKONIUM CHLORIDE BENZALKONIUM WATER ALOE VERA LEAF GLYCERIN POTASSIUM SORBATE POLYGLYCERYL-6 CAPRYLATE SODIUM BENZOATE POLYGLYCERYL-4 LAURATE
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.20 Wipes 5.5 x 7 in (14 x 17.8 cm) Simplify ® Antibacterial Hand Wipes Gentle Cleansing With aloe Scented Kills 99.9% of Most Common Germs* Dermatologist Tested 20 Hand Wipes OPEN Do Not Flush 5.5 x 7 in (14 x 17.8 cm) Front panel Graphics Drug facts Drug Facts continued
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
Drug Facts (continued)
DISTRIBUTED BY: RITE AID, 2.00 NEWBERRY COMMONS, ETTERS. PA 17319 www.riteaid.com *Testing based on a subset of FDA proposal published June 17, 1994.
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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-hands Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product Keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin Stop use and ask a doctor if irritation or redness develops condition persists for more than 72 hours
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