Label: NASAL- oxymetazoline hydrochloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 73169-002-01 - Packager: DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.
- 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 19, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- Uses
- PURPOSE
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Warnings
Ask a doctor before use if you have
heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland
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 symptoms persist.
If pregnant or breast feeding, ask a health professional before use. - KEEP OUT OF REACH OF CHILDREN
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Directions
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 spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Other information
store at room temperature. - Inactive ingredients
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NASAL
oxymetazoline hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73169-002 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73169-002-01 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 06/07/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 Part 3 1 Part 4 1 Part 1 of 4 NO MORE NOSEBLEED
oxymetazoline hydrochloride liquidProduct Information Item Code (Source) NDC:73169-001 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 (UNII: 7FLD91C86K) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 Part 2 of 4 SODIUM CHLORIDE 0.65% - NASALSALINE SPRAY
moisturizingProduct Information Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 3 of 4 VASELINE PETROLEUM JELLY
moisturizingProduct Information Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 4 of 4 BLEEDCEASE
other personal cleanliness productsProduct Information Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/07/2019 Labeler - DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. (117075364) Registrant - DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. (117075364) Establishment Name Address ID/FEI Business Operations DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC. 117075364 manufacture(73169-002)