Label: OXYMETHAZOLINE HCL spray
Contains inactivated NDC Code(s)
NDC Code(s): 68071-5014-1
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 69618-050
- 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 February 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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 10-12 hours. Do not exceed 2 doeses in 24 hours.
children under 6 years of age: ask a doctor.
Instructions for use: Shake well before use. to open, rotate cap to align the marks. Squeeze cap on toh sides in a counter-clockwise turn and pull to remove. To spray, hold bottles with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto bottle.
- Other information
- Inactive ingredients
- Questions or comments?
Ask a doctor before use if you have
high blood pressure
trouble urinating due to an enlarged prostate gland
When using this prduct
do not use more than directed
do not use 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, sneexing, or an increased nasal discharge may occur
use of this container by more than one person may spread infection
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
oxymethazoline hcl spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-5014(NDC:69618-050) 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 mg Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) EDETATE SODIUM (UNII: MP1J8420LU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) POVIDONE (UNII: FZ989GH94E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-5014-1 1 in 1 BOX; Type 0: Not a Combination Product 08/05/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2019 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-5014)