Label: NASAL MIST WALGREENS- oxymetazoline hydrochloride 0.05% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-7000-01 - Packager: Walgreens
- 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 14, 2018
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- PURPOSE
- INDICATIONS & USAGE
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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 glandWhen using this product
•do not exceed recommended dosage • do not use for more than 3 days. Use only as directed. • 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 • frequent or prolonged use may cause nasal congestion to recur or worsen
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Directions
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 use. • adults and children 6 to under1 2 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 1 0 to 1 2 hours. Do not exceed 2 doses within any 24-hour period • children under 6 years of age: consult a doctor - Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NASAL MIST WALGREENS
oxymetazoline hydrochloride 0.05% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7000 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) Water (UNII: 059QF0KO0R) Chlorhexidine Gluconate (UNII: MOR84MUD8E) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) Sodium Citrate (UNII: 1Q73Q2JULR) Sodium Hydroxide (UNII: 55X04QC32I) Tyloxapol (UNII: Y27PUL9H56) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-7000-01 1 in 1 CARTON 07/01/2016 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 07/01/2016 Labeler - Walgreens (008965063) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(0363-7000) , label(0363-7000)
