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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

Purpose

Nasal Decongestant

Description

Drug Facts


Medication Information

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
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

Inactive Ingredients

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

Description

Drug Facts

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.

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

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
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

Inactive Ingredients (Inactive ingredients)

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

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.

Active Ingredient (Active ingredient)

Oxymetazoline Hydrochloride 0.05%

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

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