NASAL MIST CVS- oxymetazoline hydrochloride 0.05% liquid 
CVS

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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Drug Facts

Active ingredient                                       Purpose

Oxymetazoline Hydrochloride 0.05%        Nasal decongestant

Uses

• for the temporary relief of nasal congestion due to
the common cold, hay fever or other upper respiratory
allergies

• shrinks swollen membranes so you can breathe
more freely

Warnings

Ask a doctor before use if you have
• heart disease• high blood pressure• thyroid disease
• diabetes• trouble urinating due to enlarged prostate gland

When using this product

•do not exceed recommended dosage • do not use for more than 3 days. Use only as directed. • 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 • frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask a doctor if symptoms persist

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Before using the first time, remove the protective cap from the tip and prime pump by depressing pump firmly several times.
To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. • adults and children 6 to under1 2 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 1 0 to 1 2 hours. Do not exceed 2 doses within any 24-hour period • children under 6 years of age: consult a doctor

Inactive ingredients


Benzalkonium Chloride
Chlorhexidine Gluconate
Citric Acid
Disodium EDTA
Fragrance
Purified Water
Sodium Citrate
Sodium Hydroxide
Tyloxapol

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NASAL MIST  CVS
oxymetazoline hydrochloride 0.05% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-435
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)  
Water (UNII: 059QF0KO0R)  
Chlorhexidine Gluconate (UNII: MOR84MUD8E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Tyloxapol (UNII: Y27PUL9H56)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-435-011 in 1 CARTON10/01/2015
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2015
Labeler - CVS (062312574)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(59779-435) , label(59779-435)

Revised: 6/2018
Document Id: 87aef7c3-3408-49ac-99b9-5459b6820131
Set id: 952ddc51-da0d-4fa4-9f13-94cf3c3ad458
Version: 4
Effective Time: 20180614
 
CVS