Label: ROHTO COOL MAX- naphazoline hydrochloride, polysorbate 80 liquid
- NDC Code(s): 10742-8159-1
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 8, 2023
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- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
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
- Directions
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
ROHTO COOL MAX
naphazoline hydrochloride, polysorbate 80 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8159 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 0.3 mg in 1 mL POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 80 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8159-1 1 in 1 CARTON 05/05/2014 1 13 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 05/05/2014 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 label(10742-8159) Establishment Name Address ID/FEI Business Operations Rohto-Mentholatum (Vietnam) Co. Ltd. 555347535 manufacture(10742-8159)