ROHTO COOL- naphazoline hydrochloride, polysorbate 80 liquid 
The Mentholatum Company

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Drug Facts

Active ingredients

Naphazoline hydrochloride 0.012%

Polysorbate 80 0.2%

Purpose

Naphazoline hydrochloride - Redness reliever

Polysorbate 80 - Lubricant

Uses

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

Inactive ingredients

alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified water, sodium borate

Questions?

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

Package/Label Principal Display Panel

Rohto Cool
ROHTO  COOL
naphazoline hydrochloride, polysorbate 80 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8142
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.12 mg  in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 802 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M) 1 mg  in 1 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
CHLOROBUTANOL (UNII: HM4YQM8WRC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8142-11 in 1 CARTON08/21/2001
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 DrugM01808/21/2001
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
Rohto-Mentholatum (Vietnam) Co. Ltd.555347535manufacture(10742-8142)

Revised: 12/2024
Document Id: 2978e70a-6498-3b0d-e063-6394a90a88fd
Set id: 69166dec-fb86-4c76-9efe-88c3bb12a8f0
Version: 15
Effective Time: 20241217
 
The Mentholatum Company