ROHTO HYDRA hydroxyethyl cellulose liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) (HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) - UNII:S38J6RZN16)

Available from:

Rohto Pharmaceutical Co. Ltd.

INN (International Name):

HYDROXYETHYL CELLULOSE - UNII:S38J6RZN16)

Composition:

HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 6 mg in 1 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

ROHTO HYDRA- HYDROXYETHYL CELLULOSE LIQUID
ROHTO PHARMACEUTICAL CO. LTD.
_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%
PURPOS E
Hydroxyethyl cellulose - Lubricant
US ES
•
•
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
•
•
•
•
STOP USE AND ASK A DOCTOR IF
•
•
•
•
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
tightly snap on cap to seal
INACTIVE INGREDIENTS
temporarily relieves discomfort due to minor irritations of the eye or
exposure to win or sun
lubricates to prevent further irritation or to relieve dryness of the
eye
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
you feel eye pain
changes in vision occur
redness or irritation of the eyes lasts
condition worsens or lasts more than 72 hours
benzalkonium chloride, boric acid, edetate disodium, menthol,
polysorbate 80, potassium chloride,
purified water, sodium borate, sodium chloride
QUES TIONS ?
1-877-636-2677 MON - FRI 9 AM - 5 PM (EST)
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
ROHTO HYDRA
hydroxyethyl cellulose liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 6 6 13-8 148
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
HYDRO XYETHYL CELLULO SE ( 2 0 0 0 MPA.S AT 1%) (UNII: S38 J6 RZN16 )
(HYDROXYETHYL CELLULOSE (20 0 0 MPA.S AT 1%) - UNII:S38 J6 RZN16 )
HYDROXYETHYL
CELLULOSE (20 0 0 MPA.S AT
6 mg
in 1 mL
Rohto Pharmaceutical Co. Ltd.
(HYDROXYETHYL CELLULOSE (20 0 0 MPA.S AT 1%) - UNII:S38 J6 RZN16 )
1%)
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG