Label: NASAL- oxymetazoline hydrochloride spray
- NDC Code(s): 63187-701-15, 63187-701-30
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-5711
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 1, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
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- diabetes
- •
- trouble urinating due to enlarged prostate gland
When using this product
- 1.
- do not exceed recommended dosage
- 2.
- do not use for more than 3 days. Use only as directed.
- 3.
- may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
- 4.
- the use of this container by more than one person may spread infection
- 5.
- frequent or prolonged use may cause nasal congestion to recur or worsen
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Directions
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- 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
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- do not exceed 2 doses within any 24-hour period
- •
- children under 6 years of age: consult a doctor
To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use
- Other information
- STORAGE AND HANDLING
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 15 mL Carton
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INGREDIENTS AND APPEARANCE
NASAL
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-701(NDC:0904-5711) Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride 5 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Benzalkonium Chloride (UNII: F5UM2KM3W7) Edetate Disodium (UNII: 7FLD91C86K) Propylene Glycol (UNII: 6DC9Q167V3) Benzyl Alcohol (UNII: LKG8494WBH) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Hydrochloric Acid (UNII: QTT17582CB) Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-701-15 15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/02/2016 2 NDC:63187-701-30 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/02/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/17/2009 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-701)
