Label: NASAL DECONGESTANT- oxymetazoline hcl spray
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Contains inactivated NDC Code(s)
NDC Code(s): 67510-0669-1 - Packager: Kareway Product, Inc.
- 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 23, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Do not use this product 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
When using this product
- do not exceed recommended dosage
- use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen
- temporary discomfort such as burning, stinging, or an increase in nasal discharge may occur
- use of this container by more than one person may spread infection
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Directions
- To spray, squeeze bottle qiuckly and firmly
- Do not tilt head backward while spraying
- Wipe nozzle clean after use
- Do not exceed 2 doses in any 24 hour period
- 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
- chlidren under 6 years of age: ask a doctor
- Other information
- Inactive ingredients
- Carton image
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INGREDIENTS AND APPEARANCE
NASAL DECONGESTANT
oxymetazoline hcl sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0669 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0669-1 1 in 1 BOX 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/23/2015 Labeler - Kareway Product, Inc. (121840057)