Label: EYE DROPS- tetrahydrozoline hydrochloride solution/ drops
- NDC Code(s): 0536-0940-94
- Packager: Rugby Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Tetrahydrozoline HCl 0.05%Close
- relieves redness of the eye due to minor eye irritations
Do not use if solution changes color or becomes cloudy
Ask a doctor before use if you have
narrow angle glaucoma
When using this product
- do not touch tip of container to any surface to avoid contamination
- overuse may produce increased redness of the eye
- pupils may become enlarged temporarily
Stop use and ask a doctor if
- you experience eye pain, changes in vision, continued redness or irritation of the eye
- condition worsens or persists for more than 72 hours
- Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.Close
- instill 1 to 2 drops in the affected eye(s) up to four times daily
- Other information
- store at 15° - 30°C (59° - 86°F)
- keep tightly closed
- replace cap after use
- Inactive ingredients
boric acid, edetate disodium, sodium borate, sodium chloride, purified water.
Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
PRESERVATIVE: benzalkonium chloride 0.01%Close
- Questions or comments?
9 am - 5 pm ET, Monday-Friday.
Serious side effects associated with use of this product may be reported to this number.Close
- Package/Label Principal Display Panel
COMPARED TO ACTIVE INGREDIENT IN VISINE® ORIGINAL*
Tetrahydrozoline HCl 0.05%
Ophthalmic Solution, USP
1/2 fl oz (15 mL)
- INGREDIENTS AND APPEARANCE
tetrahydrozoline hcl solution/ drops
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-0940 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-0940-94 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 10/07/2011 Labeler - Rugby Laboratories Inc. (109178264) Registrant - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 196603781 MANUFACTURE