Label: QUALITY CHOICE NASAL- oxymetazoline hydrochloride spray
- NDC Code(s): 63868-079-01
- Packager: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
- 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 January 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Ask a doctor before use if you have
When using this product
- do not use more than directed
- do not use for 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, sneezing or an increase in nasal discharge may occur
- 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.
- 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. Push down cup while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim 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. Replace clip under rim and secure cap after use.
- Other information
- Inactive ingredients
Package/Label Principal Display Panel
*Compare to active ingredient in Afrin® No Drip Extra Moisturizing Pump Mist
12 Hour Relief
Nasal Mist No Drip
Oxymetazoline HCl 0.05%
Fast, powerful Congestion Relief
For Colds & Allergies
Dry Nasal Passages
No Drip Pump Mist Won’t Drip from Nose or Down Throat
1 FL OZ (30mL)
100% QC SATISFACTION GURANTEED
IMPORTANT: Keep this carton for future reference on full labeling.
How to use:
Push down cup while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.
Distributed by C.D.M.A., Inc. ©
43157 W. Nine Mile
Novi, MI 48376-0995
*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin® Extra Moisturizing.
INGREDIENTS AND APPEARANCE
QUALITY CHOICE NASAL
oxymetazoline hydrochloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-079 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE .05 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-079-01 1 in 1 CARTON 04/17/2019 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 04/17/2019 Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)