INFANT NASAL ANNE GEDDES- sodium chloride liquid
HR Pharma LLC

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.

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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)

Label

Box

INFANT NASAL ANNE GEDDES
sodium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69976-002
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	.65 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69976-002-02	1 in 1 CARTON	07/13/2015	11/18/2016
1	NDC:69976-002-01	15 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	07/13/2015	11/18/2016

Labeler - HR Pharma LLC (079850639)

Registrant - FLEET LABORATORIES LTD (217269489)

Name	Address	ID/FEI	Business Operations
Establishment
FLEET LABORATORIES LTD		217269489	manufacture(69976-002)

Revised: 6/2018

Document Id: 8934d8b5-2886-4133-ad77-26779ebc769b

Set id: 901b5a27-4d26-411e-a172-002929bbcd51

Version: 8

Effective Time: 20180619

HR Pharma LLC