FDA.reportPublic FDA data

CLARA 1984

Manufacturer
CLARA GROUP
Effective date
2015-01-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:19

Label at a glance#

ProductCLARA 1984
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: DIMETHICONE 1.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Vaseline, Sophora Japanese, Myrobalan, Ginger, Madder, Akanthopanax, Gomphocarpus, Zigadenus, Liquidambar, Aristolochia, Anacamptis, Cinnamon, Saffron powder, Wild rose, Peppermint, violet , Olive

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Moisturizing, Protection

WARNINGS

WARNINGS SECTION

Warnings:
During the summer time store in refrigerator. and Place product at room temperature for else seasons. /
Not recommended for children under 4 years. / Expiration period: 2 years

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Not recommended for children under 4 years.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications and Usage:
Spread thoroughly for full moisture.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration:
Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200010dimethicone 1 % Topical CreamPSN1
200010dimethicone 10 MG/ML Topical CreamSCD1
200010dimethicone 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69404-010-012020-01-31C16284748780-19d75b9cf-d69d-f424-e053-dadaa90a57ce1bb643eb-4707-4316-82fa-7d3839b91bed

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69404-010-01CLARA 198450 mL in 1 CARTONCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69404-010CLARA 1984 (DIMETHICONE) CREAM [CLARA GROUP]1Legacy NDC, 1 package rows20150109_1bb643eb-4707-4316-82fa-7d3839b91bed.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
CinnamonINACTIVE INGREDIENT5S29HWU6QB1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69404-01069404-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
Cinnamon5S29HWU6QBIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CinnamonCINNAMON5S29HWU6QBCAPSULE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
CinnamonCINNAMON5S29HWU6QBELIXIR / ORAL10.5 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates

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
e6eab4f4-4670-4be4-bbd1-888105554b0c1bb643eb-4707-4316-82fa-7d3839b91bed2015-01-09WarningsExact identifier
spl id: e6eab4f4-4670-4be4-bbd1-888105554b0c
spl set id: 1bb643eb-4707-4316-82fa-7d3839b91bed

Reported adverse events (FAERS/openFDA)#

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