FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5

Manufacturer
Cosmetique Active Production
Effective date
2023-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:49

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Cicaplast Defense B5
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69625-587-01La Roche Posay Laboratoire Dermatologique Cicaplast Defense B540 mL in 1 TUBEGEL402
69625-587-01La Roche Posay Laboratoire Dermatologique Cicaplast Defense B51 in 1 CARTONGEL12
69625-587-02La Roche Posay Laboratoire Dermatologique Cicaplast Defense B53 mL in 1 TUBEGEL32
69625-587-02La Roche Posay Laboratoire Dermatologique Cicaplast Defense B51 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69625-587LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5 (GLYCERIN) GEL [COSMETIQUE ACTIVE PRODUCTION]2Current NDC, 4 package rows20231212_01c8a0d5-bcd1-4639-be45-530a226401f0.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
69625-58769625-587-01, 69625-587-02

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 B5GLYCERINCosmetique Active Production01c8a0d5-bcd1-4639-be45-530a226401f02023-12-11WarningsExact identifier
ndc (package): 69625-587-02
ndc (package): 69625-587-01
ndc (product): 69625-587
ndc11 (package): 69625058701
ndc11 (package): 69625058702
spl id: ffa0730d-097a-45f4-96a5-f56763bb26bd
spl set id: 01c8a0d5-bcd1-4639-be45-530a226401f0

Reported adverse events (FAERS/openFDA)#

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