We Care

We Care
SPL v2
SPL
SPL Set ID 8e33d7b8-2966-40da-8cee-789ef51cf317
Route
NASAL
Published
Effective Date 2016-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (5 g)
Inactive Ingredients
Water Benzalkonium Chloride Edetate Sodium Propylene Glycol Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic Povidone Polyethylene Glycol 1450

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-08-23

Description

Drug Facts

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Drug Facts

Uses
  • temporary relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • shrinks swollen nasal membranes so you can breathe more freely
Section 42229-5

Drug Facts

Section 44425-7
  • store between 20° to 25° C (68° to 77° F)
  • retain carton for future reference on full labeling.
Section 50565-1

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

Section 50566-9

Stop use and ask doctor if symptoms persist.

Section 50567-7

When using this product: do not use more than directed

  • do not use 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 an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection
Section 50569-3

Ask a doctor before use if you have

  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
Section 53414-9

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

Directions
  • 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

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Inactive Ingredients

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

Questions Or Comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel 15 Ml Carton

WE CARE

12 Hour NASAL SPRAY

DECONGESTANT

oxymetazoline hydrochloride 0.05%

Compare to active ingredient of Afrin


Structured Label Content

Uses
  • temporary relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • shrinks swollen nasal membranes so you can breathe more freely
Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)
  • store between 20° to 25° C (68° to 77° F)
  • retain carton for future reference on full labeling.
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if symptoms persist.

Section 50567-7 (50567-7)

When using this product: do not use more than directed

  • do not use 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 an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
Section 53414-9 (53414-9)

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

Purpose

Nasal Decongestant

Directions
  • 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

Active Ingredient (Active ingredient)

Oxymetazoline Hydrochloride 0.05%

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or Comments?)

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel 15 Ml Carton (PRINCIPAL DISPLAY PANEL - 15 mL Carton)

WE CARE

12 Hour NASAL SPRAY

DECONGESTANT

oxymetazoline hydrochloride 0.05%

Compare to active ingredient of Afrin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)