Country: United States
Language: English
Source: NLM (National Library of Medicine)
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077), ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)
Geiss, Destin & Dunn, Inc.
OPHTHALMIC
OTC DRUG
Purposes Tetrahydrozoline HCl ... Redness reliever Zinc sulfate ...Astringent Use - for temporary relief of discomfort and redness of the eye due to minor eye irritations
OTC monograph final
GOODSENSE EYE DROPS IRRITATION RELIEF- TETRAHYDROZOLINE HCL, ZINC SULFATE SOLUTION GEISS, DESTIN & DUNN, INC. ---------- GOOD SENSE EYE DROPS IRRITATION (PLD) _ACTIVE INGREDIENTS_ Tetrahydrozoline HCl ... 0.5 _%_ Zinc sulfate ... 0.25% _PURPOSES_ Tetrahydrozoline HCl ... Redness reliever Zinc sulfate ...Astringent _USE_ for temporary relief of discomfort and redness of the eye due to minor eye irritations _WARNINGS_ FOR EXTERNAL USE ONLY ASK A DOCTOR BEFORE USE IF YOU HAVE narrow angle glaucoma 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 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 IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a 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 15º-30ºC (59º-86ºF) _INACTIVE INGREDIENTS_ benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate. GOODSENSE EYE DROPS IRRITATION RELIEF tetrahydrozoline hcl, zinc sulfate solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:50804-121 ROUTE OF ADMINISTRATION OPHTHALMIC ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZ OLINE HYDROCHLORIDE 0.05 g in 100 mL ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.25 g in 100 mL INACTIVE INGREDIENTS Geiss, Destin & Dunn, Inc. INGREDIENT NAME STRENGTH BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACI Read the complete document