ROHTO ARCTIC- hypromellose, tetrahydrozoline hydrochloride 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.

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Drug Facts

Active ingredients

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 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

Other information

•
do not store above at 25°C (77°F)
•
tightly snap on cap to seal

Inactive ingredients

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

Questions or comments?

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

Package/Label Principal Display Panel

Rohto Arctic Redness Relief Redness Reliever

Rohto Arctic Redness Relief

Redness Reliever, Lubricant Eye Drops

Principal Display Panel

Rohto Arctic
ROHTO  ARCTIC
hypromellose, tetrahydrozoline hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8144
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES3.5 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:10742-8144-11 in 1 CARTON08/24/200603/31/2017
113 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/24/200603/31/2017
Labeler - The Mentholatum Company (002105757)

Revised: 11/2016
Document Id: bf21a686-e306-4dc9-b962-5d313bbc6c9d
Set id: 06b72ff2-2cdb-4a03-8dc1-d2e500c844c1
Version: 4
Effective Time: 20161102
 
The Mentholatum Company