CVS HEALTH- nasal oxymetazoline hcl spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)
Available from:
CVS Pharmacy,Inc.
Administration route:
NASAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nasal Decongestant
Authorization status:
OTC monograph final
Authorization number:
69842-575-15

CVS HEALTH- nasal oxymetazoline hcl spray

CVS Pharmacy,Inc.

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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CVS Health Nasal Spray OXYMETAZOLINE HCl 12 Hour Spray ½ FL OZ

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpos e

Nasal Decongestant

Us es

Warnings

Ask a doctor before use if you have

When using this product

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.

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

respiratory allergies

temporarily relieves sinus congestion and pressure

shrinks swollen nasal membranes so you can breathe more freely

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

do not use more than directed

do not use for more than 3 days. Use only as directed. Frequent and prolonged use may cause nasal

congestion to recur and to worsen

temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may

occur

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

If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222)

Directions

Other information

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene

glycol ,purified water, sodium phosphate dibasic, sodium phosphate monobasic.

Principal Display Panel

CVS Health

Compare to the active ingredient in Afrin® Original*

NDC 69842-575-15

Original

Nasal Spray

OXYMETAZOLINE HCl

Nasal decongestant

12 HOUR NASAL SPRAY

Fast, Powerful Congestion Relief

1/2 FL OZ (15 mL)

DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSNG

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Bayer Inc., the distributor of Afrin Original

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive,

Woonsocket, RI 02895

© 2015 CVS/pharmacy

CVS.com

1-800-SHOP CVS

CVS Quality

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 within any 24-hour

period.

children under 6 years of age: ask a doctor. To spray, squeeze bottle quickly and firmly. Do not

tilt head backward while spraying. Wipe nozzle clean after use.

store between 20°-25°C (68°-77°F)

Money back Guarantee

CVS HEALTH

nasal oxymetazoline hcl spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-575

Route of Administration

NASAL

CVS Pharmacy,Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O XYMETAZO LINE HYDRO CHLO RIDE (UNII: K8 9 MJ0 S5VY) (OXYMETAZOLINE -

UNII:8 VLN5B44ZY)

OXYMETAZOLINE

HYDROCHLORIDE

0 .0 5 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: 22ADO53M6 F)

SO DIUM PHO SPHATE, MO NO BASIC, ANHYDRO US (UNII: KH7I0 4HPUU)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 8 42-575-

1 in 1 CARTON

0 4/18 /20 19

1

15 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 4/18 /20 19

Labeler -

CVS Pharmacy,Inc. (062312574)

Revised: 9/2020

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