New Zealand - English - Medsafe (Medicines Safety Authority)

bausch & lomb (nz) ltd - tetracaine hydrochloride 1% - eye drops, solution - 1 % - active: tetracaine hydrochloride 1% excipient: hydrochloric acid purified water - ocular anaesthetic for topical instillation into the conjunctival sac.

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch health ireland limited - tetracaine hydrochloride - eye drops, solution - 0.5 percent weight/volume - local anesthetics; tetracaine

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch health ireland limited - tetracaine hydrochloride - eye drops, solution - 1.0 percent weight/volume - local anesthetics; tetracaine

United States - English - NLM (National Library of Medicine)

paragon bioteck, inc. - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv) - tetracaine hydrochloride ophthalmic solution usp, 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. tetracaine hydrochloride ophthalmic solution, usp, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution usp, 0.5% in pregnant women. animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. risk summary there are no data to assess whether tetracaine hydrochloride ophthalmic solution usp, 0.5% is excreted in human milk or to assess its effects on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetracaine hydrochloride ophthalmic solution usp, 0.5% and any potential adverse effects on the breastfed child from tetracaine hydro

United States - English - NLM (National Library of Medicine)

oceanside pharmaceuticals - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv) - tetracaine hydrochloride ophthalmic solution, usp 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. tetracaine hydrochloride ophthalmic solution, usp 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution, usp 0.5% in pregnant women. animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. risk summary there are no data to assess whether tetracaine hydrochloride ophthalmic solution, usp 0.5% is excreted in human milk or to assess its effects on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetracaine hydrochloride ophthalmic solution, usp 0.5% and any potential adverse effects on the breastfed child from tetracaine hydroc

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv) - tetracaine hydrochloride ophthalmic solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. none. risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution 0.5% in pregnant women.  animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. risk summary there are no data to assess whether tetracaine hydrochloride ophthalmic solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetracaine hydrochloride ophthalmic solution 0.5% and any potential adverse effects on the breastfed child from tetracaine hydrochloride ophthalmic solution 0.5% or from the underlying maternal condition. no human data on the effect of tetracaine hydrochlo

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

bausch + lomb ireland - tetracaine hydrochloride 10 mg/ml - eq. tetracaine 8,79 mg/ml - eye drops, solution - 10 mg/ml - tetracaine hydrochloride 10 mg/ml - tetracaine

United States - English - NLM (National Library of Medicine)

bausch health us llc - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv) - tetracaine hydrochloride ophthalmic solution, usp 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. tetracaine hydrochloride ophthalmic solution, usp 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution, usp 0.5% in pregnant women. animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. risk summary there are no data to assess whether tetracaine hydrochloride ophthalmic solution, usp 0.5% is excreted in human milk or to assess its effects on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetracaine hydrochloride ophthalmic solution, usp 0.5% and any potential adverse effects on the breastfed child from tetracaine hydroc

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv) - tetracaine hydrochloride ophthalmic solution, usp 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. tetracaine hydrochloride ophthalmic solution, usp 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution, usp 0.5% in pregnant women. animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. risk summary there are no data to assess whether tetracaine hydrochloride ophthalmic solution, usp 0.5% is excreted in human milk or to assess its effects on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetracaine hydrochloride ophthalmic solution, usp 0.5% and any potential adverse effects on the breastfed child from tetracaine hydrochloride ophthalmic solution, usp 0.5%. no human data on the effect of tetracaine hydrochloride ophthalmic solution, usp 0.5% on fertility are available. safety of tetracaine hydrochloride ophthalmic solution, usp 0.5% in the pediatric population has been demonstrated in clinical trials. efficacy of tetracaine hydrochloride ophthalmic solution, usp 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. no overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution, usp 0.5% have been observed between elderly and younger patients.

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch + lomb ireland limited - tetracaine hydrochloride - eye drops, solution - local anesthetics; tetracaine