SEVERE NASAL- oxymetazoline hydrochloride 0.05% spray 
ALAINA HEALTHCARE PRIVATE LIMITED

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Severe Nasal Spray

Drug Facts

Active ingredient                                                                                                                                              Purpose

Oxymetazoline hydrochloride 0.05% ............................................................................................... Nasal decongestant

Uses

temporarily relieves

Warnings

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland

When using this product

  • do not exceed recommended dosage
  • Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing or increased nasal discharge may occur
  • use of this container by more than one person may spread infection

Stop use and ask a doctor if

  • symptoms persist

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information -do not exceed 25°C

Inactive ingredients

aloe barbadensis leaf extract, benzalkonium chloride, disodium EDTA, polyethylene glycol, PVP, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphste monobasic

Principal Display Panel

SEVERE Nasal Spray
Oxymetazoline HCl 0.05 %
Nasal Decongestant
SUPER-FINE Moisturizing MIST
- Helps relieve sinus congestion & pressure
- Soothing aloe
0.5 FL OZ (15mL)

oxymetazoline-container.jpg
SEVERE NASAL 
oxymetazoline hydrochloride 0.05% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73492-715
Route of AdministrationNASAL
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73492-715-151 in 1 CARTON09/15/2023
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/15/2023
Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)
Establishment
NameAddressID/FEIBusiness Operations
ALAINA HEALTHCARE PRIVATE LIMITED858720927manufacture(73492-715)

Revised: 12/2023
Document Id: 0c38b320-8979-7d06-e063-6294a90acf14
Set id: 27747a10-8d1d-41c2-80b9-45452f3b9abc
Version: 2
Effective Time: 20231211
 
ALAINA HEALTHCARE PRIVATE LIMITED