ROHTO HYDRA- hydroxyethyl cellulose (2000 mpa.s at 1%) liquid 
The Mentholatum 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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Drug Facts

Active ingredient

Hydroxyethyl cellulose 0.6%

Purpose

Hydroxyethyl cellulose - Lubricant

Uses

temporarily relieves discomfort due to minor irritations of the eye or exposure to wind or sun
lubricates to prevent further irritation or to relieve dryness of the eye

Warnings

For external use only

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
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) as needed

Other information

store at 20-25 °C (68-77°F)
tightly snap on cap to seal

Inactive ingredients

boric acid, edetate disodium, menthol, polysorbate 80, potassium chloride, purified water, sodium borate, sodium chloride, sodium chondroitin sulfate

Questions?

Toll free 1-877-636-2677 MON-FRI 9AM to 5PM (EST) consumeraffairs@mentholatum.com

Package/Label Principal Display Panel

Principal Display Panel

Rohto Hydra

Principal Display Panel

Rohto Hydra
ROHTO HYDRA 
hydroxyethyl cellulose liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10742-8148
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)) HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
EDETATE DISODIUM 
MENTHOL 
POLYSORBATE 80 
POTASSIUM CHLORIDE 
WATER 
SODIUM BORATE 
SODIUM CHLORIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8148-11 in 1 CARTON
113 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/03/2011
Labeler - The Mentholatum Company (002105757)

Revised: 1/2014
Document Id: 853d75d7-2e09-41f7-b17a-4dcc3925df04
Set id: e830ced3-f624-4d94-b62e-2a7bc4ed9187
Version: 4
Effective Time: 20140124
 
The Mentholatum Company