Label: NASAL DECONGESTANT- oxymetazoline hcl spray
- NDC Code(s): 67510-0068-1, 67510-0068-5
- 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 March 31, 2023
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- 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
- Shake well before use.
- To spray, remove the clear plastic cap.
- Hold bottle with thumb at base and nozzle between first and second fingers. If this is the first time you are using the pump, spray several times into the air until you get a fine mist. If you have not used the pump for 14 days, spray several times into the air before using again.
- Insert nozzle into nostril. Spray upward while breathing in through the nose. Repeat in other nostril.
- Wipe nozzle clean after use. Put clear plastic cap back on the bottle
- 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 spray in each nostril not more often than every 10 to 12 hours children 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:67510-0068 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0068-5 1 in 1 BOX 08/12/2011 1 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:67510-0068-1 1 in 1 BOX 08/12/2011 2 30 mL in 1 BOTTLE, PUMP; 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 08/12/2011 Labeler - Kareway Product, Inc. (121840057)
