FDA.reportPublic FDA data

Cleanoz

Manufacturer
Laboratoires Gifrer Barbezat
Effective date
2010-03-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:23:51

Label at a glance#

ProductCleanoz
Active ingredientsodium chloride
Label structure7 sections

Indications and uses

Recommended for nasal rinsing in babies, children and adults. Recommended for the following cases: Hygiene of nasal passage: Pollution, dry air, airconditioning, dust, pollen. Moisture efficiency. Nasal drainage. For babies and infants, this can be assisted with the use of Cleanoz ® nasal aspirator kit TM

Storage and handling

Twist and pull tab to remove. Tilt on the applicator to obtain the necessary dosage. Directions for use for babies and infants: Place the baby with its head leaning to the side. Place carefully the tip of the applicator in one nostril. Tilt to obtain the necessary dosage. Repeat on the other nostril. Use as often as needed for any length of time or as directed by physician. Non habit forming. Other information Sto...

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

  • Recommended for nasal rinsing in babies, children and adults.
Recommended for the following cases:
  • Hygiene of nasal passage: Pollution, dry air, airconditioning, dust, pollen.
  • Moisture efficiency.
  • Nasal drainage. For babies and infants, this can be assisted with the use of Cleanoz® nasal aspirator kitTM

Warning

WARNINGS SECTION

For external use only, do not inject

  • Do not use if solution changes color or becomes cloudy.

OTC - WHEN USING SECTION

When using this product

  • Use only if applicator is intact.
  • To avoid contamination, do not touch tip of the container to any surface.
  • Do not reuse. Once opened, discard.
  • Do not use the same applicator on different people.

Direction

STORAGE AND HANDLING SECTION

  • Twist and pull tab to remove.
  • Tilt on the applicator to obtain the necessary dosage.
  • Directions for use for babies and infants: Place the baby with its head leaning to the side. Place carefully the tip of the applicator in one nostril. Tilt to obtain the necessary dosage. Repeat on the other nostril.
  • Use as often as needed for any length of time or as directed by physician. Non habit forming.
Other information
  • Store at 68-77°F (20-25°C).
  • Retain this carton for future reference.
  • Use before expiration date marked on the carton or containers.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Purified water, 0.9% Sodium Chloride

OTC - QUESTIONS SECTION

Questions?   1-866-5-UBIMED   info@ubimed.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cleanoz(R)

Saline solution

Natural relief for dry or stuffy noses

Convenient and hygienic

Newborns to adults

The #1 Choice of Healthcare Professionals

Preservative-free vials

Ubimed

3/5/10/20/30/40 Count

3/5/10/20/30/40 Sterile Single-Use Applicators

5mL (0.169 FL OZ) Each

carton label picture
carton label picture

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044606cleanoz 0.9 % Nasal SolutionPSN4
313000sodium chloride 0.9 % Nasal SolutionPSN4
1044606sodium chloride 9 MG/ML Nasal Solution [Cleanoz Saline]SBD4
313000sodium chloride 9 MG/ML Nasal SolutionSCD4
1044606Cleanoz Saline 0.154 MEQ/ML Nasal SolutionSY4
1044606Cleanoz Saline 0.9 % Nasal SolutionSY4
313000NaCl 9 MG/ML Nasal SolutionSY4
1044606NaCl 9 MG/ML Nasal Solution [Cleanoz Saline]SY4
313000sodium chloride 0.9 % Nasal SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44929-002-022019-10-21C16284748780-1956f9ecf-c3d8-621f-e053-dbdaa90a74ad835dc7e4-6efb-4890-af4e-eaf9469601cf
44929-002-032019-10-21C16284748780-1956f9ecf-c3d8-621f-e053-dbdaa90a74ad835dc7e4-6efb-4890-af4e-eaf9469601cf
44929-002-042019-10-21C16284748780-1956f9ecf-c3d8-621f-e053-dbdaa90a74ad835dc7e4-6efb-4890-af4e-eaf9469601cf
44929-002-052019-10-21C16284748780-1956f9ecf-c3d8-621f-e053-dbdaa90a74ad835dc7e4-6efb-4890-af4e-eaf9469601cf
44929-002-062019-10-21C16284748780-1956f9ecf-c3d8-621f-e053-dbdaa90a74ad835dc7e4-6efb-4890-af4e-eaf9469601cf
44929-002-072019-10-21C16284748780-1956f9ecf-c3d8-621f-e053-dbdaa90a74ad835dc7e4-6efb-4890-af4e-eaf9469601cf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44929-002-01Cleanoz5 mL in 1 AMPULESOLUTION54
44929-002-02Cleanoz20 in 1 CARTONSOLUTION204
44929-002-03Cleanoz3 in 1 CARTONSOLUTION34
44929-002-04Cleanoz5 in 1 CARTONSOLUTION54
44929-002-05Cleanoz40 in 1 CARTONSOLUTION404
44929-002-06Cleanoz10 in 1 CARTONSOLUTION104
44929-002-07Cleanoz30 in 1 CARTONSOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44929-002CLEANOZ (SODIUM CHLORIDE) SOLUTION [LABORATOIRES GIFRER BARBEZAT]4Legacy NDC, 7 package rows20100311_835dc7e4-6efb-4890-af4e-eaf9469601cf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
sodium chlorideACTIVE INGREDIENT451W47IQ8X4
sodium cationACTIVE MOIETYLYR4M0NH374
waterINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44929-00244929-002-01, 44929-002-02, 44929-002-03, 44929-002-04, 44929-002-05, 44929-002-06, 44929-002-07

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
sodium chloride451W47IQ8XACTIB
water059QF0KO0RIACT

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
7336682d-094c-4f71-9e15-6854ed73e304835dc7e4-6efb-4890-af4e-eaf9469601cf2010-03-11WarningsExact identifier
spl id: 7336682d-094c-4f71-9e15-6854ed73e304
spl set id: 835dc7e4-6efb-4890-af4e-eaf9469601cf

Reported adverse events (FAERS/openFDA)#

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