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

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Drug Facts - Rohto Cool Max

Active ingredients

Naphazoline hydrochloride 0.03%

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 top 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

Other information

Inactive ingredients

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

Questions?

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

Package/Label Principal Display Panel

Rohto Cool Max
ROHTO  COOL MAX
naphazoline hydrochloride, polysorbate 80 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8159
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.3 mg  in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 802 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)  
POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8159-11 in 1 CARTON05/05/2014
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 DrugM01805/05/2014
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757label(10742-8159)
Establishment
NameAddressID/FEIBusiness Operations
Rohto-Mentholatum (Vietnam) Co. Ltd.555347535manufacture(10742-8159)

Revised: 12/2024
Document Id: 2978d571-17d3-2c20-e063-6394a90a14cd
Set id: 20b934af-fe24-44a2-b313-5540a209432c
Version: 9
Effective Time: 20241217
 
The Mentholatum Company