equate Nasal Decongestant super-fine moisturizing mist by ALAINA HEALTHCARE PRIVATE LIMITED equate TMNasal Spray

Drug Details [pdf]

EQUATE NASAL DECONGESTANT SUPER-FINE MOISTURIZING MIST- oxymetazoline hydrochloride 0.05% spray
ALAINA HEALTHCARE PRIVATE LIMITED

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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equate TMNasal Spray

Drug Facts

Active ingredient Purpose

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

Uses

temporarily relieves

nasal congestion due to a cold, hay fever, or other upper respiratory allergies
sinus congestion and pressure

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

Adults & children 6 years & older (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 2 to under 6 years: ask a doctor.
Children under 2 years: do not use.

Other information -do not exceed 25°C

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Questions or comments?

1-888-287-1915

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

Principal Display Panel

equate TM

Nasal Spray

Oxymetazoline HCl 0.05%

NDC: 73492-713-15

Nasal Decongestant

Super-Fine Moisturizing Mist

0.5 FL OZ (15 mL)

EQUATE NASAL DECONGESTANT SUPER-FINE MOISTURIZING MIST
oxymetazoline hydrochloride 0.05% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73492-713
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 73492-713-15	1 in 1 CONTAINER	07/18/2023	09/30/2023
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/18/2023	09/30/2023

Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)

Name	Address	ID/FEI	Business Operations
Establishment
ALAINA HEALTHCARE PRIVATE LIMITED		858720927	manufacture(73492-713)

Revised: 9/2023

Document Id: 068f0480-b434-debe-e063-6394a90a859a

Set id: f3b096da-93b0-4b78-a75e-ce48178f3d2c

Version: 4

Effective Time: 20230930