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Rohto Ice by Rohto-Mentholatum (Vietnam) Co. Ltd.

Medically reviewed on July 10, 2017

Dosage form: liquid
Ingredients: HYPROMELLOSES 2mg in 1mL, TETRAHYDROZOLINE HYDROCHLORIDE .5mg in 1mL, ZINC SULFATE 2.5mg in 1mL
Labeler: Rohto-Mentholatum (Vietnam) Co. Ltd.
NDC Code: 75977-8143

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 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 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, contact a Poison Control Center right away.

Directions

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

Other information

tightly snap on cap to seal

Inactive ingredients

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

Package/Label Principal Display Panel
ROHTO ICE 
hypromellose, tetrahydrozoline hcl, zinc sulfate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75977-8143
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSES (HYPROMELLOSES) HYPROMELLOSES2 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE.5 mg  in 1 mL
ZINC SULFATE (ZINC CATION) ZINC SULFATE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
BORIC ACID 
MENTHOL 
POLYSORBATE 80 
WATER 
SODIUM BORATE 
Packaging
#Item CodePackage Description
1NDC:75977-8143-11 BOTTLE, WITH APPLICATOR in 1 CARTON
113 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/01/2011
Labeler - Rohto-Mentholatum (Vietnam) Co. Ltd. (555270813)

 
Rohto-Mentholatum (Vietnam) Co. Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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