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| Product NDC Code | 53329-768 | ||||
|---|---|---|---|---|---|
| Drug Name | Medline |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 865073 | ||||
| Application Number | M016 | ||||
| Labeler Name | Medline Industries, LP | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc oxide 25% w/w
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 shake well before using for skin protection apply as needed for diaper rash change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aleurites moluccanus (kukui) seed oil, allantoin, aphanizomenon flos aquae extract, astrocaryum murumuru seed butter, butylene glycol, camellia sinensis (green tea) leaf extract, caprylic/capric triglyceride, cetyl alcohol, 7-dehydrocholesterol, dehydroxanthan gum, dicaprylyl carbonate, diisopropyl adipate, dimethicone, ethylhexylglycerin, eugenia caryophyllus (clove) flower extract, gelidiella acerosa (algae) extract, glycerin, hydrolyzed soy protein, hypnea musciformis (algae) extract, magnesium sulfate, PEG-30 dipolyhydroxystearate, phenoxyethanol, phospholipids, polyamide-8, polyglyceryl-3 diisostearate, polyhydroxystearic acid, propanediol, propylene glycol dicaprylate/dicaprate, sorbitan sesquioleate, tetrafluoropropene, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zeolite
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 helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Medline zinc oxide .ALPHA.-TOCOPHEROL ACETATE ALLANTOIN APHANIZOMENON FLOSAQUAE CETYL ALCOHOL DIISOPROPYL ADIPATE WATER ZEA MAYS (CORN) OIL KUKUI NUT OIL GELIDIELLA ACEROSA PHENOXYETHANOL POLYAMIDE-8 (4500 MW) POLYGLYCERYL-3 DIISOSTEARATE POLYHYDROXYSTEARIC ACID (2300 MW) 1,3,3,3-TETRAFLUOROPROPENE, (1Z)- DEHYDROXANTHAN GUM EUGENIA CARYOPHYLLUS (CLOVE) FLOWER EXTRACT OMEGA-3 FATTY ACIDS PROPANEDIOL PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYLENE GLYCOL YEAST EXTRACT GLYCERIN MAGNESIUM SULFATE DIMETHICONE DICAPRYLYL CARBONATE SORBITAN SESQUIOLEATE ETHYLHEXYLGLYCERIN HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) HYPNEA MUSCIFORMIS EXTRACT CAMELLIA SINENSIS LEAF ZINC OXIDE ZINC OXIDE 7-DEHYDROCHOLESTEROL ASTROCARYUM MURUMURU SEED BUTTER PEG-30 DIPOLYHYDROXYSTEARATE ZEOLITE A CAPRYLIC/CAPRIC TRIGLYCERIDE
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 label
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.Manufacturing information www.medline.com ©2023 Medline and Medline Remedy are registered trademarks of Medline Industries, LP. Made in the USA of foreign and domestic materials. Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA. 1-800-MEDLINE V1 RG23FZS
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.Do not use on deep or puncture wounds animal bites serious burns
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F.
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 condition worsens symptoms last for more than 7 days or clear up and occur again within a few days
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 do not get into eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect from freezing, avoid excessive heat Nonflammable
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 on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor condition worsens symptoms last for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F.
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