La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose

DIMETHICONE TOPICAL HUMAN OTC DRUG

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose is an FDA drug label for the active ingredient DIMETHICONE manufactured by L'Oreal USA Products Inc 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 20260910.

Generic name
DIMETHICONE
Manufacturer
L'Oreal USA Products Inc
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
49967-744
Application
M016
Label effective
20260910

About this product

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose is an FDA-registered drug product whose active ingredient is DIMETHICONE. It is labelled by L'Oreal USA Products Inc taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 49967-744, application M016, label effective 20260910. 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, chafed chapped, cracked skin, drying effects, cold weather. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Dimethicone 1%

Indications & Usage

Uses temporarily protects and helps relieve chafed, chapped or cracked skin helps protect from the drying effects of wind and cold weather helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Dosage & Administration

Directions apply as needed For diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Warnings

Warnings F or external use only

More products with the same ingredient

DIMETHICONE

AFTER CARE

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Claravie Skin Repair Cream

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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

Frequently asked questions

What is La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose used for?
Uses temporarily protects and helps relieve chafed, chapped or cracked skin helps protect from the drying effects of wind and cold weather helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Who makes La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose?
L'Oreal USA Products Inc is the labeler of record for La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose. 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 La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose 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 La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose 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 La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.