Active Ingredient
Zinc oxide 25% w/w
Medline Spray
FDA Label NDC 53329-768
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Medline (NDC 53329-768). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
- helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
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.
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
Other Information
- Protect from freezing, avoid excessive heat
- Nonflammable
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
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
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