FAMILY CARE NASAL RELIEF- oxymetazoline hydrochloride spray

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

Buy It Now

Active ingredient:
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)
Available from:
United Exchange Corp
Administration route:
NASAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - temporarily relieves nasal congestion due to: - common cold - hay fever - upper respiratory allergies - temprarily relieves sinus congestion and pressure - shrinks swollen nasal membranes so you can breathe more freely Stop use and ask a doctor if symptoms persist Directions - adults and children 6 to 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 does in any 24-hour period. - children under 6 years of age: ask a doctor. Shake well before use. Remove safety seal. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap onto bottle.
Authorization status:
OTC monograph final
Authorization number:
65923-571-15

FAMILY CARE NASAL RELIEF- oxymetazoline hydrochloride spray

United Exchange Corp

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.

----------

Family Care Nasal Spray Severe Congestion 0.5 oz NBE Afrin Severe Congestion 571 (2018)

ZDP

Active ingredient Purpose

Oxymetazoline HCl 0.05%...............................................Nasal decongestant

Us es

temporarily relieves nasal congestion due to:

common cold

hay fever

upper respiratory allergies

temprarily relieves sinus congestion and pressure

shrinks swollen nasal 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 an enlarged prostate gland

When using this product

do not use more than directed

do not use 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 an increase in 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 (1-

800-222-1222) right away.

Directions

adults and children 6 to 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 does in any 24-hour period.

children under 6 years of age: ask a doctor. Shake well before use. Remove safety seal. To open,

rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to

remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and

second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm,

even stroke and sniff deeply. Wipe nozzle clean after use and snap cap onto bottle.

Other information

store between 20° and 25°C (66° and 77°F)

Inactive ingredients benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol,

menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium

phosphate monobasic monohydrate

Distributed by:

United Exchange Corp

Cypress, CA 90630 USA

1-888-645-8204

Made in China

FAMILY CARE NASAL RELIEF

oxymetazoline hydrochloride spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 59 23-571

United Exchange Corp

Route of Administration

NASAL

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

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

EUCALYPTO L (UNII: RV6 J6 6 0 4TK)

WATER (UNII: 0 59 QF0 KO0 R)

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

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

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

MENTHO L (UNII: L7T10 EIP3A)

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

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

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 59 23-571-

1 in 1 CARTON

0 5/25/20 18

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 5/31/20 13

Labeler -

United Exchange Corp (840130579)

Revised: 12/2019

Similar products

Search alerts related to this product

View documents history

Share this information