REDNESS RELIEVER- tetrahydrozoline hcl liquid 
American Sales Company

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 Original

Active Ingredient


Tetrahydrozoline HCl 0.5%

Purpose

Redness reliever

Use

Warnings


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.
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lenses before using

Stop use and ask a doctor if

you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for 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

Other information

Inactive ingredients

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

package label

Care One Redness Reliever

carton

REDNESS RELIEVER 
tetrahydrozoline hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-531
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-531-051 in 1 BOX09/06/2011
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 finalpart34909/06/2011
Labeler - American Sales Company (809183973)

Revised: 2/2023
Document Id: f4ee870c-a1df-1d42-e053-2a95a90ada2d
Set id: 3222b6d6-adb6-4747-b764-84a19bd5cc34
Version: 4
Effective Time: 20230217
 
American Sales Company