Label: ORIGINAL NO DRIP NASAL- oxymetazoline hydrochloride - 0.05% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-1231-1 - Packager: Rite Aid
- 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 June 15, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- Uses
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Warnings
Do not use this product if you have heart disease • high
blood pressure • thyroid disease
• diabetes • or difficulty in urination due to enlargement of
the prostate gland
When using this product • 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. Use only as
directed. • Frequent or prolonged use may cause nasal
congestion to recur or worsen.
Stop use and ask doctor if symptoms persist,
consult a doctor - Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
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Direction
Shake well before use. Before using the first time, remove
the protective cap from the tip and prime pump by
depressing pump firmly several times. To spray, hold bottle
with thumb at base and nozzle between first and second
fingers. Without tilting head, insert nozzle into nostril Fully depress rim with a firm,
even stroke and sniff deeply.
Wipe nozzle clean after each use.
• 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. Do not
exceed 2 doses in any 24-hour
period.
• children under 6 years of
age: consult a doctor - OTHER SAFETY INFORMATION
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORIGINAL NO DRIP NASAL
oxymetazoline hydrochloride - 0.05% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1231 Route of Administration TOPICAL 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 ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) Povidone (UNII: FZ989GH94E) Sodium Phosphate (UNII: SE337SVY37) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1231-1 1 in 1 CARTON 05/09/2014 1 15 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 05/09/2014 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(11822-1231) , label(11822-1231)
