RUGBY TETRAHYDROZOLINE OPHTHALMIC SOLUTION- tetrahydrozoline hcl solution/ drops 
Rugby Laboratories

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Rugby Tetrahydrozoline Ophthalmic Solution (PLD)

Active Ingredient

Tetrahydrozoline HCI 0.05%

Purpose

Redness Reliever

Use

relieves redness in eye due to minor eye irritations

Warnings

For external use only

Warnings

Ask a doctor before use if you have narrow angle glaucoma

Warnings

When using this product

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

Warnings

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

Warnings

If pregnant or breast-feeding, ask a professional before use.

Warnings

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

Directions

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Other Information

store at 15°-30°C (59°-86°F)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Questions or Comments?

1-800-645-2158

Rugby Tetrahydrozoline Ophthalmic Solution

Rugby Tetrahydrozoline  Ophthalmic Solution

RUGBY TETRAHYDROZOLINE OPHTHALMIC SOLUTION 
tetrahydrozoline hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1217
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BORIC ACID (UNII: R57ZHV85D4)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1217-941 in 1 BOX06/08/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01806/08/2019
Labeler - Rugby Laboratories (079246066)
Registrant - K.C. Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
K.C. Pharmaceuticals, Inc.174450460manufacture(0536-1217) , pack(0536-1217) , label(0536-1217)

Revised: 12/2023
Document Id: 0cf9c0f6-3ef9-a74f-e063-6394a90aa22f
Set id: 8ac5ec94-17c2-9991-e053-2995a90a6a7c
Version: 2
Effective Time: 20231220
 
Rugby Laboratories