ROHTO ICE- hypromellose, tetrahydrozoline hydrochloride, zinc sulfate liquid

Rohto by

Drug Labeling and Warnings

Rohto by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company, Rohto-Mentholatum (Vietnam) Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 eyes 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 before use 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 more 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, get medical help or contact a Poison Control Center right away.

Directions

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

• tightly snap on cap to seal

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

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

Questions?

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

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ROHTO  ICE
hypromellose, tetrahydrozoline hydrochloride, zinc sulfate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8143
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	2 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE, UNSPECIFIED FORM	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8143-1	1 in 1 CARTON	09/27/2005
1		13 mL in 1 BOTTLE, WITH APPLICATOR; 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	09/27/2005

Labeler - The Mentholatum Company (002105757)