REDNESS RELIEVER  - tetrahydrozoline hcl liquid 
Navarro Discount Pharmacies,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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Drug Facts

Active Ingredient

Tetrahydrozoline HCl 0.5%

Purpose

Redness reliever

Use

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

When using this product

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • do not use if this solution changes color or become cloudy
  • overuse may cause more eye redness
  • remove contact lens before using

Stop use and ask a doctor if

you experience:

  • eye pain
  • changes in vision
  • redness or irritation of the eye or if condition worsens or persists more than 72 hours

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

Other information

Inactive ingredients

benzalkonium chloride, boric acid, dilite hydrochloric acid, edetate disodium, purified water, sodium borate, sodium chloride

package label

Sterile Eye Drops Originalimage of carton label

REDNESS RELIEVER  
tetrahydrozoline hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-050
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59970-050-051 in 1 BOX
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/02/2012
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 8/2011
Document Id: 9e7416f6-23af-4ebb-8788-c1b62db35a3b
Set id: 60cda9f7-60c0-4ca5-ac6e-2f35f7d6e6d5
Version: 1
Effective Time: 20110811
 
Navarro Discount Pharmacies,LLC