Label: NASAL DECONGESTANT- oxymetazoline hcl spray
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- NDC Code(s): 71205-219-30
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-6761
- 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 October 1, 2019
If you are a consumer or patient please visit this version.
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- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
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When using this product
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- do not use more than directed
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- do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
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- temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
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- use of this container by more than one person may spread infection
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
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- 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: ask a doctor
To Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime metered 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. Secure cap after use.
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
NASAL DECONGESTANT
oxymetazoline hcl sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-219(NDC:0904-6761) 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 BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) EDETATE DISODIUM (UNII: 7FLD91C86K) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Product Characteristics Color WHITE (to off white, viscous) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-219-30 1 in 1 CARTON 02/01/2019 1 30 mL in 1 BOTTLE, SPRAY; 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 10/12/2018 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-219) , RELABEL(71205-219)
