OXYMETAZOLINE HYDROCHLORIDE  12-HOUR- oxymetazoline hydrochloride spray 
Taro Pharmaceuticals U.S.A., 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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Oxymetazoline Hydrochloride
Nasal Decongestant 12-Hour Spray

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

Warnings

Do not exceed recommended dosage

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

Do not use

  • for more than 3 days

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

When using this product

  • frequent or prolonged use may cause nasal congestion to recur or worsen

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 right away.

Directions

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), polyethylene glycol 1450, povidone, propylene glycol, purified water.

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

Compare to the
active ingredient
in Afrin ®*

Nasal
Decongestant
12- Hour Spray

Oxymetazoline
Hydrochloride 0.05%

Maximum Strength

Contains the Active Ingredient
Recommended Most by
Physicians and Pharmacists

12

1 fl oz (30 mL)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
OXYMETAZOLINE HYDROCHLORIDE   12-HOUR
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2030
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride (UNII: F5UM2KM3W7)  
sodium phosphate, dibasic, anhydrous (UNII: 22ADO53M6F)  
edetate disodium (UNII: 7FLD91C86K)  
sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)  
polyethylene glycol 1450 (UNII: OJ4Z5Z32L4)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2030-51 in 1 CARTON02/25/2006
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC:51672-2030-31 in 1 CARTON02/25/2006
230 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 FINALpart34102/25/2006
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.117337220MANUFACTURE(51672-2030)

Revised: 1/2019
Document Id: b6e8883a-066f-44a5-ab4e-fe507bbf861d
Set id: 34a79f8b-32b7-48db-a895-c942cc795292
Version: 2
Effective Time: 20190115
 
Taro Pharmaceuticals U.S.A., Inc.