REXALL SINUS NASAL PUMP MIST- oxymetazoline hydrochloride 0.05% liquid 
Dollar General

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 Facts

Active ingredients                                        Purpose

Oxymetazoline Hydrochloride 0.05%            Nesal Decongestant

Uses

temporarily relief nasal decongestion due to:
- common cold
- hay fever
- upper respiratory allergies
- shrinks swollen membranes
- temporarily restores freer breathing through the nose

Do not use this product if person has heart disease, high blood pressure, thyroid disease, diabetes, or if adult has difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

When using this product
Do not exceed recommended dosage.
This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.

The use of this container by more than one person may spread infection

Stop use and ask doctor if

Symptoms persist

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of the children

Directions. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor

shake well before each use. Before using for the first time remove the protective cap from the tip and prime mitered pump by depressing pump firmly several times. To remove the cap, squeeze cap at the base on opposite sides on the two smooth impressions with fingers. While squeezing, twist cap counterclockwise to remove. Remove clip and press down to use. Refer to directions on top of each cap. To reapply cap, turn cap on pump clockwise until it locks. To spray, hold bottle with thumb at base and nozzle between first and second flingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.

Inactive ingredients

Benzalkonium Chloride
Camphor
Disodium EDTA
Disodium Phosphate
Eucalyptol
Menthol
Polysorbate 20
Propylene Glycol
Sodium Phosphate
Water

image description

REXALL SINUS NASAL PUMP MIST 
oxymetazoline hydrochloride 0.05% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-778
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
EUCALYPTOL (UNII: RV6J6604TK)  
Menthol (UNII: L7T10EIP3A)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Phosphate (UNII: SE337SVY37)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-778-0130 mL in 1 PACKAGE; Type 0: Not a Combination Product12/21/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/21/2015
Labeler - Dollar General (068331990)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(55910-778) , label(55910-778)

Revised: 10/2017
Document Id: 3bbc1dcc-0b12-4340-a2b5-146fca3dbd47
Set id: b273d489-38ed-47be-a3f1-10c9ee1a3eef
Version: 1
Effective Time: 20171004
 
Dollar General