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Product NDC Code | 59062-5000 | ||||
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Drug Name | Baby essentials gift set |
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Type | Brand | ||||
Dosage Form | KIT | ||||
Application Number | part333E | ||||
Labeler Name | KAS Direct LLC dba BabyGanics | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium Chloride 0.1%
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 pump a small amount of foam into palm of hand rub thoroughly over all surfaces of both hands rub hands together briskly until dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, medium chain triglycerides, triethyl citrate, citrus reticulata (mandarin orange) peel oil, tocopherol, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil
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 for hand sanitizing to decrease bacteria on the skin recommended for repeated use
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.baby essentials gift set Benzalkonium Chloride moisturizing daily water COCOA BUTTER cetyl alcohol squalene decyl oleate shea butter propanediol glycerin AVOCADO OIL OLIVE OIL canola oil tocopherol ALOE VERA LEAF TOMATO SEED OIL SUNFLOWER OIL CRANBERRY SEED OIL NIGELLA SATIVA SEED RASPBERRY SEED OIL CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER stearic acid YELLOW WAX CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE sodium hydroxide caprylyl glycol TRISODIUM ETHYLENEDIAMINE DISUCCINATE sorbic acid phenoxyethanol bubble bath water sodium lauroyl methyl isethionate disodium cocoamphodiacetate coco glucoside lauryl glucoside capryl/capramidopropyl betaine TOMATO SEED OIL SUNFLOWER OIL CRANBERRY SEED OIL NIGELLA SATIVA SEED RASPBERRY SEED OIL ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER CHAMOMILE OLEA EUROPAEA LEAF glycerin CITRIC ACID MONOHYDRATE TRISODIUM ETHYLENEDIAMINE DISUCCINATE PHENOXYETHANOL ethylhexylglycerin sodium benzoate squeeze and foam shampoo plus body wash water sodium lauroyl methyl isethionate CAPRYLYL/CAPRYL OLIGOGLUCOSIDE propanediol BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) sodium lauroyl oat amino acids glycerin ethylhexylglycerin CITRIC ACID MONOHYDRATE trisodium ethylenediamine disuccinate dehydroacetic acid TOMATO SEED OIL SUNFLOWER OIL CRANBERRY SEED OIL NIGELLA SATIVA SEED RASPBERRY SEED OIL PHENOXYETHANOL sodium hydroxide PHYTATE SODIUM ALOE VERA LEAF CUCUMBER CHAMOMILE AVOCADO tocopherol BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER MANDARIN BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM water cetrimonium chloride laurtrimonium chloride dihydroxyethyl cocamine oxide glycereth-17 cocoate MEDIUM-CHAIN TRIGLYCERIDES triethyl citrate TANGERINE tocopherol ORANGE OIL CITRUS MAXIMA FRUIT RIND OIL toy, table and highchair wipes water glycerin decyl glucoside malic acid potassium sorbate gluconolactone sodium benzoate DIRECT BLACK 19 foaming dish and bottle soap water cocamidopropyl hydroxysultaine lauramine oxide decyl glucoside sodium lauroyl sarcosinate glycerin methylisothiazolinone
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.PRINCIPAL DISPLAY PANEL - Kit Package babyganics baby essentials gift set 1- daily lotion chamomile verbena (9 FL OZ) 1- bubble bath chamomile verbena (9 FL OZ) 1- foaming shampoo+body wash chamomile verbena (7 FL OZ) 1- foaming dish & bottle soap fragrance free (3 FL OZ) 1- toy, table & highchair wipes fragrance free (25 wipes) 2- alcohol-free foaming hand sanitizer mandarin (50 ML) Discover which ingredients are Certified Organic on bottom panel. PRINCIPAL DISPLAY PANEL - Kit Package
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
dist. by KAS direct, LLC Westbury, NY 11590
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 right away.
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.Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
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.When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
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 When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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