Active Ingredient
Dimethicone 2% (w/v)
Medline Lotion
FDA Label NDC 53329-251
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 53329-251). 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, use, 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
Use
- helps treat and prevent diaper rash. Protect minor skin irritation due to 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
- if condition worsens
- symptoms last 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.
Directions
- change wet and soiled diapers promptly
- spray affected area and gently wipe with clean, soft cloth to cleanse
- apply product liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.
Inactive Ingredients
allantoin, cetearyl alcohol, citric acid, diazolidinyl urea, fragrance, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, panthenol, propylene glycol, propylparaben, sodium lauroyl lactylate, soybean oil, tocopheryl acetate (vitamin E), water, zinc ricinoleate.
Other Information
- protect from freezing
- avoid excessive heat
- store at 15°C - 30°C (59°F - 86°F)
Questions?
1-800-MEDLINE (633-5463)
Manufacturing Information
www.medline.com
©2025 Medline, Medline Remedy and Baza are registered trademarks of Medline Industries, LP.
Manufactured by: Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA.
Made in USA of foreign and domestic materials
1-800-MEDLINE
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