ROHTO SUN AND SPORT- hypromellose, povidone liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO), POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E)

Available from:

The Mentholatum Company

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

Hypromellose – Lubricant Povidone - Lubricant - for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun - protects against further irritation or to relieve dryness of the eye

Authorization status:

OTC monograph final

Summary of Product characteristics

ROHTO SUN AND SPORT- HYPROMELLOSE, POVIDONE 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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Hypromellose 0.3%
Povidone 0.5%
PURPOSE
Hypromellose – Lubricant
Povidone - Lubricant
USES
for the temporary relief of discomfort due to minor irritations of the
eye or to
exposure to wind or sun
protects against 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
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 persists for 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
tightly snap on cap to seal
_OTHER INFORMATION_
do not store above 25
C (77
F)
INACTIVE INGREDIENTS
alginic acid, anhydrous citric acid, boric acid, camphor,
chlorobutanol, edetate disodium,
menthol, polysorbate 80, purified water, sodium borate, sodium
citrate, taurine, zinc
sulfate
QUESTIONS?
1-877-636-2677 MON-FRI 9AM-5PM (EST)
PRINCIPAL DISPLAY PANEL
O
O
ROHTO SUN AND SPORT
hypromellose, povidone liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:10742-8140
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE,
UNSPECIFIED - UNII:3NXW29V3WO)
HYPROMELLOSE,
UNSPECIFIED
3 mg
in 1 mL
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED -
UNII:FZ 989GH94E)
POVIDONE,
UNSPECIFIED
5 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALGINIC ACID (UNII: