NASAL- oxymetazoline hydrochloride spray 
We Care Distributor 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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We Care
12 Hour NASAL SPRAY
DECONGESTANT

Drug Facts

Active ingredient

Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

Warnings

Ask a doctor before use if you have

  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland

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

Stop use and ask 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

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use

Other information

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

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NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-038
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
POVIDONE (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-038-011 in 1 CARTON08/23/2016
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/23/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
PURINE PHARMA LLC019950491manufacture(70005-038)

Revised: 8/2016
Document Id: f19d2b1b-74ac-43b3-9a83-56dba094c7d3
Set id: 8e33d7b8-2966-40da-8cee-789ef51cf317
Version: 2
Effective Time: 20160823
 
We Care Distributor Inc.