RINOSAN MINT NASAL DECONGESTANT- ephedrine hydrochloride spray 
Bee Right LLC

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.

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Rinosan MINT Nasal Decongestant Spray

Drug Facts

Active Ingredient

Ephedrine Hydrochloride 0.5%

Purpose

Nasal Decongestant

Uses

Warnings

Consult a doctor before use if you have:

• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland 

When using this product

  • use of this container by more than one person may spread infection
  • this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
  • do not use this product for more than 3 days; use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen

Do not

  • exceed recommended  dosage

Stop use and consult a doctor if:

symptoms persist

If pregnant or breastfeeding,

consult a health care professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

 Adults and children 12 year of age and over 2 or 3 sprays in each nostril not more than once every 4 hours
 Children 6 to under 12 years of age (with adult supervision) 1 or 2 sprays in each nostril not more than once every 4 hours
 Children under 6 years of age Consult a doctor

Other information

Inactive ingredients

Benzalkonium chloride, calcium chloride, disodium phosphate, eucalyptus globulus oil, menthol, potassium chloride, sodium chloride, water

Package Labeling:

Outer Package3Inner Package3

RINOSAN MINT NASAL DECONGESTANT 
ephedrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71952-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MENTHOL (UNII: L7T10EIP3A)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71952-030-001 in 1 BOX07/01/2018
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2018
Labeler - Bee Right LLC (080988303)

Revised: 7/2018
Document Id: 701603fa-befe-111c-e053-2991aa0ae2b4
Set id: 1239e824-aa60-4b7f-9910-81f96ebe6c70
Version: 3
Effective Time: 20180703
 
Bee Right LLC