ROHTO RELIEF- hypromellose, tetrahydrozoline hcl, zinc sulfate 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

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 eye irritations
∘: exposure to wind and 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

Inactive ingredients

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

Principal Display Panel

ROHTO RELIEF
hypromellose, tetrahydrozoline hcl, zinc sulfate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66613-8149
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	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

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CHLOROBUTANOL (UNII: HM4YQM8WRC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM ASPARTATE (UNII: OC4598NZEQ)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66613-8149-1	1 in 1 CARTON	12/01/2011	07/31/2017
1		13 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	12/01/2011	07/31/2017

Labeler - Rohto Pharmaceutical Co Ltd (690573662)

Revised: 8/2017

Document Id: 45a7fbf2-2d3d-4cb9-9759-4e6cf3f6a96e

Set id: 89c054c5-22c6-40b0-8ef8-8f6e46b56264

Version: 4

Effective Time: 20170825

Rohto Pharmaceutical Co Ltd