ROHTO ARCTIC- hypromellose, tetrahydrozoline hydrochloride 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 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

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

Ask a doctor before use if you have

narrow angle glaucoma

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

•
do not store above 25°C (77°F)

Inactive ingredients

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

Questions?

1-877-636-2677 MON - FRI 9 AM - 5 PM

Package/Label Principal Display Panel

Rohto Arctic
ROHTO ARCTIC 
hypromellose, tetrahydrozoline hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66613-8144
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 HYDROCHLORIDE0.5 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:66613-8144-11 in 1 CARTON08/24/200603/31/2017
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 finalpart34908/24/200603/31/2017
Labeler - Rohto Pharmaceutical Co Ltd (690573662)

Revised: 8/2017
Document Id: ee89f6d2-775e-4639-908a-2a6a4674c0d6
Set id: 7faee1af-c126-4786-8e6d-6c07490259fd
Version: 4
Effective Time: 20170825
 
Rohto Pharmaceutical Co Ltd