CAREONE EYE DROPS SEASONAL RELIEF- tetrahydrozoline hcl and zinc sulfate solution/ drops 
FoodHold U.S.A 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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Careone Eye Drops Seasonal Relief 0.5 oz (NBE Visine AC) 86533 2018

Active Ingredients Purposes

Tetrahydrozoline HCl 0.05%.......Eye redness reliever

Zinc sulfate 0.25%......................Eye astringent

Uses

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 (1-800-222-1222) right away.

Directions

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate

Questions or comments?

Call 1-877-846-9949

Distributed by:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

86533.2

CAREONE EYE DROPS SEASONAL RELIEF 
tetrahydrozoline hcl and zinc sulfate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-653
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
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
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:41520-653-151 in 1 BOX10/01/2018
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 finalpart34909/26/2018
Labeler - FoodHold U.S.A LLC (809183973)

Revised: 5/2019
Document Id: 87dccaf8-1fe9-516f-e053-2a95a90abf5b
Set id: 76ca7211-8d4f-f0e1-e053-2991aa0aff8f
Version: 2
Effective Time: 20190501
 
FoodHold U.S.A LLC