FDA.reportPublic FDA data

Clara

Manufacturer
Handock Cosmetics Inc
Effective date
2011-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:31

Label at a glance#

ProductClara
Active ingredientPSYLLIUM HUSK
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

active ingredient: psyllium husk powder, thistle

INACTIVE INGREDIENT SECTION

inactive ingredient: Inulin power, Indigestible maltodextrin, Kelp power, Lactulose power, Rice bran fermented power, Green tea power, L-Cystine, Propolis, Yeast Extract(B-glucan), Curcumd longa power, DL-methionine, Vitamix, Papain

OTC - PURPOSE SECTION

■ Enhances Liver function, detoxification and anti-inflammatory effects
■ Intestinal toxic emissions and health
■ Removes constipation and bad breadth
■ Dietary Fiber warranty
■ Enhances blood pressure and immune system
■ Diabetes prevention
■ Reduces Cholesterol
■ Prevention of adult diseases and osteoporosis
■ Removes Gastrointestinal Disorders and stomach gas

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

Take 1-2 pack(s) two times daily with a full glass of water, preferably before a meal

WARNINGS SECTION

■ If you are pregnant, nursing, taking any medications or planning any medical procedure, consult your doctor before
  use. Discontinue use and consult your doctor if any adverse reactions occur.
■ Please check the ingredients before taking if there are allergic or idiosyncratic symptoms
■ Do not take if the product of expiration date is expired

DOSAGE & ADMINISTRATION SECTION

■ After taking, first one or two weeks, stomach may feel uncomfortable due to nutritive functions. After that, should be oka

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
13620a32-e3b4-4aad-8280-283dce30ddffProduct name120260105
27883b46-af31-44b0-b4ce-e6b4f6d825a7Product name420250812
c1a80c95-0e51-52a0-75fa-75808f51ded8Product name220150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76369-1001-12019-10-29C16284748780-1960f7f55-d664-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76369-1001-1Clara5 g in 1 PACKETGRANULE51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76369-1001CLARA (PSYLLIUM HUSK) GRANULE [HANDOCK COSMETICS INC]1Legacy NDC, 1 package rows20110913_f8a0faa0-985a-43ca-b253-348de058fa83.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PSYLLIUM HUSKACTIVE INGREDIENT0SHO53407G1
PSYLLIUM HUSKACTIVE MOIETY0SHO53407G1
CYSTINEINACTIVE INGREDIENT48TCX9A1VT1
INULININACTIVE INGREDIENTJOS53KRJ011
KELP BASSINACTIVE INGREDIENT24ZZ99M3KV1
lactuloseINACTIVE INGREDIENT9U7D5QH5AE1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF1
RICEINACTIVE INGREDIENT659G217HPG1
TEA LEAFINACTIVE INGREDIENTGH42T47V241

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76369-100176369-1001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSYLLIUM HUSK0SHO53407GACTIB
INULINJOS53KRJ01IACT
MALTODEXTRIN7CVR7L4A2DIACT
KELP BASS24ZZ99M3KVIACT
lactulose9U7D5QH5AEIACT
RICE659G217HPGIACT
TEA LEAFGH42T47V24IACT
CYSTINE48TCX9A1VTIACT
PROPOLIS WAX6Y8XYV2NOFIACT

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 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, EFFERVESCENT / ORAL14404 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
15 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
b2ca2351-0c83-4085-b2d7-4f775d4dbf38f8a0faa0-985a-43ca-b253-348de058fa832011-08-26WarningsExact identifier
spl id: b2ca2351-0c83-4085-b2d7-4f775d4dbf38
spl set id: f8a0faa0-985a-43ca-b253-348de058fa83

Reported adverse events (FAERS/openFDA)#

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