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Infant Nasal Anne Geddes by HR Pharma LLC

Dosage form: liquid
Ingredients: SODIUM CHLORIDE .65g in 100mL
Labeler: HR Pharma LLC
NDC Code: 69976-002

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.

Infant Nasal Spray

Active ingredient (in each dose)      Purpose

Sodium Chloride  0.65%                     Moisturizer

Uses

For dry nasal membranes

Keep out of reach of Children

If symptoms persist, speak to your doctor.

Warnings:

Use of dispenser by more than one person may spread infection

Directions

For infants under 1 spray 1-2 times in each nostril and for children 2-3 times in each nostril. When using hold upright to spray

Throw away after 8 weeks of opening.

Age                          Dose

Infants under 1        1-2 sprays

Children over 1         2-3 Sprays

Inactive Ingredients:

Aqua/Water, Benzalkonium Chloride,  Disodium Phosphate, Monosodium Phosphate, Sodium Hydroxide

Anne Geddes

Infant Nasal Spray

.5 fl oz (15ml)

INFANT NASAL  ANNE GEDDES
sodium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69976-002
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE.65 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BENZALKONIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
SODIUM PHOSPHATE, MONOBASIC 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:69976-002-021 BOTTLE, UNIT-DOSE in 1 CARTON
1NDC:69976-002-0115 mL in 1 BOTTLE, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/13/2015
Labeler - HR Pharma LLC (079850639)
Registrant - FLEET LABORATORIES LTD (217269489)
Establishment
NameAddressID/FEIOperations
FLEET LABORATORIES LTD217269489manufacture(69976-002)

Revised: 03/2016
 
HR Pharma LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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