Active Ingredient
Dimethicone 12.5% w/v
Medline Cream
FDA Label NDC 53329-159
13 label sections · Submitted to the FDA by Medline Industries, Lp · 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 53329-159). 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 if, 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 If
- 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.
Directions
- change wet and soiled diapers promptly, cleans the diaper area and allow to dry
- apply cream liberally as often as necessary with each diaper change esspecially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
- protect from freezing, avoid excessive heat
Inactive Ingredients
7-dehydrocholestrol, aphanizomenon flos-aquae (algae) extract, bisabolol, brassica campestris (rapeseed) sterols, C12-13 pareth-23, C12-13 pareth-3, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) oleosomes, cetylhydroxyproline palmitamide, cholecalciferol, dimethicone crosspolymer, dimethiconol, divinyldimethicone/dimethicone copolymer emulsion, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, jojoba esters, lauryl PEG-10 tris (trimethylsiloxy) silylethyl dimethicone, manuka honey, olea europaea (olive) oil, PEG/PPG-18/18 dimethicone, phenoxyethanol, phospholipids, phytonadione, propanediol, purified water, sodium chloride, stearic acid, tocopheryl acetate, yeast ferment extract, zea mays (corn) oil.
Manufacturing Information
©2022 Medline Remedy and Meldine
are registered trademearks of Medline
Industries, LP. Made in USA of domestic and
imported materials. Manufactured for Medline
Industries, LP, Three Lakes Drive, Northfield, IL
60093 USA. 1-800-MEDLINE (633-5463)
Change To Uses Section
Added word to Uses section that was inadvertently missed, but present on current labeling.
* Please review the disclaimer below.
