Drug Facts

Manufacturer
Cosmetique Active Production | L'OREAL USA PRODUCTS, INC.
Effective date
2026-09-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-12 01:01:28

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose
Active ingredientDIMETHICONE
Label structure13 sections

Indications and 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 and administration

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

Storage and handling

● store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

F or external use only

Do not use

OTC - DO NOT USE SECTION

  • on deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

● store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

wwater, hydrogenated polyisobutene, dimethicone, glycerin, butyrospermum parkii (shea) butter, panthenol, zea mays (corn) starch, propanediol, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, trihydroxystearin, centella asiatica leaf extract, polymnia sonchifolia root juice, zinc gluconate, madecassoside, manganese gluconate, alpha-glucan oligosaccharide, silica, aluminum hydroxide, magnesium sulfate, mannose, capryloyl glycine, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, acetylated glycol stearate, maltodextrin, pentylene glycol, polyglyceryl-4 isostearate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-LRP-LABO  1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133606000437449GTIN-13: 3606000437449
EAN-13: 3606000437449
GTIN storage (14 digits): 03606000437449
40mL.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69625-74369625-743-01, 69625-743-02, 69625-743-03, 69625-743-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-07-24full-release2026-06-01 01:08:36

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
ndc (package): 69625-743-03
ndc (package): 69625-743-02
ndc (package): 69625-743-01
ndc (package): 69625-743-04
ndc (product): 69625-743
ndc11 (package): 69625074301
ndc11 (package): 69625074304
ndc11 (package): 69625074302
ndc11 (package): 69625074303
spl id: 5b22cd9e-83b3-4537-e063-6394a90a2e3f
spl set id: d19f482c-bec7-45aa-b22f-fe91a3dc717d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.