FAMILY CARE ADVANCED FORMULA EYE- tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400, povidone solution/ drops 
United Exchange Corp

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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Family Care Eye Drops Advanced Formula 0.5oz 511A DW (2020)

Active ingredients                                                                            Purpose

Tetrahydrozoline HCl 0.05%.............................................................Redness reliever

Dextran 70 0.1%............................................................................Lubricant

Polyethylene glycol 400 1%.............................................................Lubricant

Povidone 1%.................................................................................Lubricant

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 the 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, edetate disodium, purified water, sodium chloride, and sodium borate

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

Made in South Korea

511A

FAMILY CARE ADVANCED FORMULA EYE 
tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400, povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-511
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
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-511-151 in 1 CARTON11/25/2014
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/25/2014
Labeler - United Exchange Corp (840130579)

Revised: 2/2020
Document Id: 9ee3113e-3f1c-50dc-e053-2a95a90a2eb6
Set id: 716d2f37-ae19-42b1-9d85-d07777dedaed
Version: 6
Effective Time: 20200218
 
United Exchange Corp