ROHTO ARCTIC- hypromellose, tetrahydrozoline hydrochloride liquid 
Rohto-Mentholatum (Vietnam) 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 0.35%

Tetrahydrozoline hydrochloride 0.05%

Purpose

Hypromellose - Lubricant

Tetrahydrozoline hydrochloride - Redness reliever

Uses

•
temporarily relieves burning and irritation due to dryness of the eye
•
relieves redness of the eye due to minor eye irritations

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 use

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 contace a Poison Control Center right away.

Directions

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

Inactive ingredients

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

Package/Label Principal Display Panel

Rohto Arctic Redness Reliever, Lubricant Eye Drops
ROHTO ARCTIC 
hypromellose, tetrahydrozoline hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75977-8144
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) (HYPROMELLOSE 2208 (100 MPA.S) - UNII:B1QE5P712K) HYPROMELLOSE 2208 (100 MPA.S)3.5 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75977-8144-11 in 1 CARTON03/01/201201/01/2014
113 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/01/201201/01/2014
Labeler - Rohto-Mentholatum (Vietnam) Co. Ltd. (555270813)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
Rohto-Mentholatum (Vietnam) Co. Ltd.555347535MANUFACTURE(75977-8144)

Revised: 8/2017
Document Id: 4ed4cf7b-f26b-4426-a853-3226a539908e
Set id: cf652b48-3da3-4527-bf0f-8ddfc77f66a0
Version: 4
Effective Time: 20170825
 
Rohto-Mentholatum (Vietnam) Co. Ltd.