Label: RUGBY TETRAHYDROZOLINE OPHTHALMIC SOLUTION- tetrahydrozoline hcl solution/ drops
- NDC Code(s): 0536-1217-94
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only
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
- Directions
- Other Information
- Inactive ingredients
- Questions or Comments?
- Rugby Tetrahydrozoline Ophthalmic Solution
-
INGREDIENTS AND APPEARANCE
RUGBY TETRAHYDROZOLINE OPHTHALMIC SOLUTION
tetrahydrozoline hcl solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1217 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1217-94 1 in 1 BOX 06/08/2019 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 06/08/2019 Labeler - Rugby Laboratories (079246066) Registrant - K.C. Pharmaceuticals, Inc. (174450460) Establishment Name Address ID/FEI Business Operations K.C. Pharmaceuticals, Inc. 174450460 manufacture(0536-1217) , pack(0536-1217) , label(0536-1217)