Active Ingredient
Dimethicone 1.5% w/v
Medline Cream
FDA Label NDC 53329-155
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 53329-155). 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, when using this product, stope 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 prevent and temporarily protects and helps relieve chapped or cracked skin
- helps prevent and protect from the drying effects of wind and cold weather
Warnings
For external use only
Do Not Use
- deep or puncture wounds
- animal bites
- serious burns
When Using This Product
- do not get into eyes
Stope 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.
In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Directions
- apply one ounce to full body per application, twice daily
- apply especially right after bath or shower for best effect
Other Information
- protect from freezing
- avoid excessive heat
- not made with Natural Rubber Latex
Inactive Ingredients
acetyl cysteine, aloe barbadensis leaf juice, arginine, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol, citric acid, dimethyl sulfone, ethylhexylglycerin, glycerin, glyceryl stearate SE, glycine, hydrated silica, niacinamide, olea europaea (olive) fruit oil, olea europaea leaf extract, olea europaea leaf powder, oleuropein, PEG-8, PEG-100 stearate, phenoxyethanol, proline, propanediol, pyridoxine HCL, retinyl palmitate, stearic acid, stearyl alcohol, taurine, tetrasodium glutamate diacetate, tocopherol, water, zea mays (corn) oil
Manufacturing Information
Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA with domestic and foreign materials
www.medline.com
1-800-MEDLINE (633-5463)
REF: MSC0924402UNS
V1 RG23WAR
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