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

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

Questions?

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

Principal Display Panel

Rohto Hydra
ROHTO HYDRA 
hydroxyethyl cellulose liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8148
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) (HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) - UNII:S38J6RZN16) HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 6 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHOL (UNII: L7T10EIP3A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10742-8148-1 1 in 1 CARTON 01/03/2011
1 13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 01/03/2011
Labeler - The Mentholatum Company (002105757)

Revised: 11/2014
Document Id: 61108b87-9e63-47c0-9a9d-b37217196c5a
Set id: e830ced3-f624-4d94-b62e-2a7bc4ed9187
Version: 5
Effective Time: 20141106
 
The Mentholatum Company