FREDS ASTRINGENT RDENESS RELIEVER EYE - tetrahydrozoline hydrochloride solution 
Freds Inc

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 ingredients                                                                                  Purpose

Tetrahydrozoline HCl 0.05%......................................................Redness Reliever

Zinc Sulfate 0.25%..............................................................................Astringent

Uses

Warnings for external use only

Ask a doctor before use if you have narrow angle glaucoma

When using this product

Stop use and ask a doctor if

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

Other information

Inactive ingredients benzalkonium chloride, boric acid, disodium edetate hydrate, purified water, sodium chloride, sodium citrate

Distributed By:

Fred's Inc.

4300 New Getwell Rd.

Memphis, TN 38118

Made in Korea

image of carton label

FREDS ASTRINGENT RDENESS RELIEVER EYE 
tetrahydrozoline hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-124
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 mg  in 1 mg
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE0.25 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-124-151 in 1 CARTON
115 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/30/2013
Labeler - Freds Inc (005866116)

Revised: 6/2013
Document Id: 8d7ee5f2-5b40-413e-b286-8d969907d0a6
Set id: 206796e8-2ac5-42b1-8d0a-02f49d40f31c
Version: 2
Effective Time: 20130630
 
Freds Inc