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Rohto Ice by Rohto Pharmaceutical Co Ltd

Medically reviewed on October 3, 2016

Dosage form: liquid
Ingredients: HYPROMELLOSES 2mg in 1mL, TETRAHYDROZOLINE HYDROCHLORIDE 0.5mg in 1mL, ZINC SULFATE, UNSPECIFIED FORM 2.5mg in 1mL
Labeler: Rohto Pharmaceutical Co Ltd
NDC Code: 66613-8143

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 ingredients

Hypromellose 0.2%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purpose

Hypromellose - Lubricant

Tetrahydrozoline HCl - Redness reliever

Zinc sulfate - Astringent

Uses

temporarily relieves redness of the eye and discomfort due to

minor eye irritations
exposure to wind or sun
temporarily relieves burning and irritation due to dryness of the eye

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glaucoma

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

Stop use and ask a doctor if
you feel eye pain
changes in vision occur
redness or irritation of the eyes lasts
condition worsens or lasts more than 72 hours

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

put 1 or 2 drops in the affected eye(s) up to 4 times daily

tightly snap on cap to seal

Inactive ingredients

boric acid, edetate disodium, menthol, polysorbate 80, purified water, sodium borate

Questions?

Toll free 1-877-636-2677 MON - FRI 9 AM - 5 PM (EST)

Package/Label Principal Display Panel
ROHTO  ICE
hypromellose, tetrahydrozoline hcl, zinc sulfate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66613-8143
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSES (HYPROMELLOSES) HYPROMELLOSES2 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
ZINC SULFATE, UNSPECIFIED FORM (ZINC CATION) ZINC SULFATE, UNSPECIFIED FORM2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
EDETATE DISODIUM 
MENTHOL, UNSPECIFIED FORM 
POLYSORBATE 80 
WATER 
SODIUM BORATE 
Packaging
#Item CodePackage Description
1NDC:66613-8143-11 BOTTLE in 1 CARTON
113 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/27/2005
Labeler - Rohto Pharmaceutical Co Ltd (690573662)

 
Rohto Pharmaceutical 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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