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Redness reliever by Samchundang Pharm. Co., Ltd.

Medically reviewed on August 29, 2018

Dosage form: liquid
Ingredients: TETRAHYDROZOLINE HYDROCHLORIDE 0.5mg in 1mL
Labeler: Samchundang Pharm. Co., Ltd.
NDC Code: 51134-0062

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.

Drug Facts

Active IngredientTetrahydrozoline HCl 0.5%

PurposeRedness reliever

Use
  • for the relief of redness of the eye due to minor eye irritations

Warnings

Ask a doctor before use if you have narrow angle glaucoma

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

Stop use and ask a doctor if
  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts 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
  • Put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age:  ask a doctor

Other information
  • store between 15° to 25°C (59°F to 77°F)


Inactive ingredients

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

package label

Redness relief

REDNESS RELIEVER  
tetrahydrozoline hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51134-0062
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
SODIUM BORATE 
EDETATE DISODIUM 
BENZALKONIUM CHLORIDE 
SODIUM CHLORIDE 
WATER 
HYDROCHLORIC ACID 
Packaging
#Item CodePackage Description
1NDC:51134-0062-51 BOTTLE (BOTTLE) in 1 BOX
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/29/2010
Labeler - Samchundang Pharm. Co., Ltd. (687792325)
Registrant - Samchundang Pharm. Co., Ltd. (687792325)
Establishment
NameAddressID/FEIOperations
Samchundang Pharm. Co., Ltd.687792325manufacture

 
Samchundang Pharm. Co., Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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