Label: CLEANOZ- sodium chloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 44929-002-01, 44929-002-02, 44929-002-03, 44929-002-04, view more44929-002-05, 44929-002-06, 44929-002-07 - Packager: Laboratoires Gifrer Barbezat
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 11, 2010
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- Official Label (Printer Friendly)
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Uses
- Recommended for nasal rinsing in babies, children and adults.
- 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
- WHEN USING
- Keep out of reach of children.
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Direction
- 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.
- 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
- QUESTIONS
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INGREDIENTS AND APPEARANCE
CLEANOZ
sodium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44929-002 Route of Administration NASAL, OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium chloride (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37) sodium chloride 900 mg in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44929-002-02 20 in 1 CARTON 1 NDC:44929-002-01 5 mL in 1 AMPULE 2 NDC:44929-002-03 3 in 1 CARTON 2 NDC:44929-002-01 5 mL in 1 AMPULE 3 NDC:44929-002-04 5 in 1 CARTON 3 NDC:44929-002-01 5 mL in 1 AMPULE 4 NDC:44929-002-05 40 in 1 CARTON 4 NDC:44929-002-01 5 mL in 1 AMPULE 5 NDC:44929-002-06 10 in 1 CARTON 5 NDC:44929-002-01 5 mL in 1 AMPULE 6 NDC:44929-002-07 30 in 1 CARTON 6 NDC:44929-002-01 5 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part341 11/25/2008 Labeler - Laboratoires Gifrer Barbezat (278133806) Establishment Name Address ID/FEI Business Operations Laboratoires Gifrer Barbezat 278133806 manufacture
