FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant

Manufacturer
L'Oreal USA Products Inc | Cosmetique Active Production
Effective date
2023-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:52

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant
Active ingredientGLYCERIN
Label structure13 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

apply as needed

Storage and handling

● store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerin 21%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For 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

Other information

STORAGE AND HANDLING SECTION

● store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, dimethicone, panthenol, pentylene glycol, c30-45 alkyl dimethicone, polybutene, sodium citrate, PEG/PPG-18/18 dimethicone, citric acid, dimethiconol, polysorbate 20, madecassoside, caprylyl glycol, sodium hyaluronate, zinc gluconate, copper gluconate, manganese gluconate, tocopherol

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

image of a carton
image of a carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-586-01La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant40 mL in 1 TUBEGEL403
49967-586-01La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant1 in 1 CARTONGEL13
49967-586-02La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant3 mL in 1 TUBEGEL33
49967-586-02La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-586LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5 SKIN PROTECTANT (GLYCERIN) GEL [L'OREAL USA PRODUCTS INC]3Current NDC, 4 package rows20231212_32eaaaab-41bd-4efe-a71d-92e3a702c1e5.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-58649967-586-01, 49967-586-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
PANTHENOLWV9CM0O67ZIACT
PENTYLENE GLYCOL50C1307PZGIACT
C30-45 ALKYL METHICONENFX970DSI2IACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
SODIUM CITRATE1Q73Q2JULRIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
POLYSORBATE 207T1F30V5YHIACT
MADECASSOSIDECQ2F5O6YIYIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
COPPER GLUCONATERV823G6G67IACT
MANGANESE GLUCONATE9YY2F980SVIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

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 Defense B5 Skin ProtectantGLYCERINL'Oreal USA Products Inc32eaaaab-41bd-4efe-a71d-92e3a702c1e52023-12-11WarningsExact identifier
ndc (package): 49967-586-02
ndc (package): 49967-586-01
ndc (product): 49967-586
ndc11 (package): 49967058602
ndc11 (package): 49967058601
spl id: 7c83dea0-3331-4ad0-9a9d-036e7fa22ab2
spl set id: 32eaaaab-41bd-4efe-a71d-92e3a702c1e5

Reported adverse events (FAERS/openFDA)#

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