Aloetouch Protect Fragrance Free

DIMETHICONE TOPICAL HUMAN OTC DRUG

Aloetouch Protect Fragrance Free is an FDA drug label for the active ingredient DIMETHICONE manufactured by Medline Industries, LP administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260901.

Generic name
DIMETHICONE
Manufacturer
Medline Industries, LP
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
53329-059
Application
M016
Label effective
20260901

About this product

Aloetouch Protect Fragrance Free is an FDA-registered drug product whose active ingredient is DIMETHICONE. It is labelled by Medline Industries, LP taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 53329-059, application M016, label effective 20260901. It is one of 30 FDA drug label records sharing the active ingredient DIMETHICONE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing DIMETHICONE are most often described in connection with: diaper rash, temporarily protects, helps relieve, chapped cracked, skin help, irritation associated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Dimethicone 3.2%

Indications & Usage

Uses temporarily protects and helps relieve chapped or cracked skin help treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness

Dosage & Administration

Directions open package as designated remove cloths and thoroughly cleanse area 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 dispose of cloth in waste receptacle

Warnings

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.

More products with the same ingredient

DIMETHICONE

AFTER CARE

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How products containing DIMETHICONE compare

FDA lists 30 drug label records with DIMETHICONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Medline Industries, LP 7
— — Galderma Laboratories, L.P. 2
— — Gentell LLC 2
— — L'Oreal USA Products Inc 2
— — PMI Branded Pharmaceuticals, Inc. 2

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0035-2026 Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30. Medline Industries, LP Class II Ongoing 20251029
D-0674-2025 READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25 Medline Industries, LP Class III Ongoing 20251001
D-0604-2025 Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78. MEDLINE INDUSTRIES, LP - Northfield Class II Ongoing 20250903
D-0602-2025 ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60. MEDLINE INDUSTRIES, LP - Northfield Class II Ongoing 20250903
D-0601-2025 CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30 MEDLINE INDUSTRIES, LP - Northfield Class II Ongoing 20250903

Frequently asked questions

What is Aloetouch Protect Fragrance Free used for?
Uses temporarily protects and helps relieve chapped or cracked skin help treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness

Who makes Aloetouch Protect Fragrance Free?
Medline Industries, LP is the labeler of record for Aloetouch Protect Fragrance Free. 30 FDA label records share the active ingredient DIMETHICONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Aloetouch Protect Fragrance Free come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Aloetouch Protect Fragrance Free prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIMETHICONE?
Yes. 30 FDA drug label records list DIMETHICONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Aloetouch Protect Fragrance Free been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.