Medicine guide

Tropicamide

5 mg/mL · Solution/ Drops

  • Prescription only
  • Anticholinergic
Active substance
Tropicamide
Made by
Bausch & Lomb Incorporated

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-09-01

What it is

Anticholinergic

Used for
  • For mydriasis and cycloplegia for diagnostic procedures.
Do not take it if

Contraindicated in persons showing hypersensitivity to any component of this preparation.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
6other products contain Tropicamide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • For mydriasis and cycloplegia for diagnostic procedures.

From the official label · 2023-09-01 · DailyMed

How it works

From this product’s own US prescribing label.

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil [mydriasis].

The stronger preparation (1%) also paralyzes accommodation.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-09-01

Do not take it if

Contraindicated in persons showing hypersensitivity to any component of this preparation.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • For refraction, one or two drops of the 1% solution in the eye(s), repeated in five minutes.
  • If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect.
  • For examination of fundus, one or two drops of the 0.5% solution 15 or 20 minutes prior to examination.
  • Individuals with heavily pigmented irides may require higher strength or more doses.
  • Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours.
  • However, in some cases, complete recovery may take up to 24 hours.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • FOR TOPICAL OPHTHALMIC USE ONLY.
  • NOT FOR INJECTION.
  • This preparation may cause CNS disturbances which may be dangerous in pediatric patients.
  • The possibility of psychotic reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be considered.
  • Mydriatics may produce a transient elevation of intraocular pressure.
  • Remove contact lenses before using.
  • General The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Animal reproduction studies have not been conducted with tropicamide.
  • It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
  • Tropicamide should be given to a pregnant woman only if clearly needed.
  • It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Quoted from the official label, section “Drug Interactions”.

Use in children

  • Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients.
  • Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (see WARNINGS ).
  • Keep this and all medications out of the reach of children.

Quoted from the official label, section “Pediatric Use”.

Use in older people

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • Ocular Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide.
  • Increased intraocular pressure has been reported following the use of mydriatics.
  • Non-Ocular Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.
  • Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.
  • To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Do not touch dropper tip to any surface, as this may contaminate the solution.
  • Patients should be advised not to drive or engage in potentially hazardous activities while pupils are dilated.
  • Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation.
  • Parents should be warned not to get this preparation in their child’s mouth and wash their own hands and the child’s hands following administration.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

  • Tropicamide ophthalmic solution USP, 1% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes:
  • NDC 24208-585-59:
  • 2 mL in a 7.5 mL bottle NDC 24208-585-64:
  • 15 mL in a 15 mL bottle Tropicamide ophthalmic solution USP, 0.5% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following size:
  • NDC 24208-590-64:
  • 15 mL in a 15 mL bottle Storage:
  • Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
  • Keep container tightly closed.
  • Keep out of reach of children.
  • Distributed by: Bausch & Lomb Americas Inc.
  • Bridgewater, NJ 08807 USA Manufactured by:
  • Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised:
  • September 2023 9115807 (Folded) 9115907 (Flat) donotuse

Quoted from the official label, section “How Supplied”.

What is in it

  • Tropicamide ophthalmic solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths.
  • The active ingredient is represented by the following chemical structure:
  • Chemical name:
  • Benzeneacetamide, N -ethyl-α-(hydroxymethyl)- N -(4-pyridinylmethyl)- Each mL contains:
  • Active:
  • tropicamide 5 mg (0.5%) or 10 mg (1%);
  • Inactives: boric acid, hydrochloric acid, edetate disodium dihydrate, purified water.
  • Sodium hydroxide and/or hydrochloric acid (to adjust pH) pH range 4.0 - 5.8.
  • Preservative: benzalkonium chloride 0.01%.
  • ChemStructure-Tropicamide.jpg

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (2)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 2 of 2

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

FranceNo exact match for this strength and form

CanadaNo exact match for this strength and form

NetherlandsNo exact match for this strength and form

Details

Made byBausch & Lomb Incorporated
Active substanceTropicamide
Strength5 mg/mL
FormSolution/ Drops
RouteOphthalmic
Packs1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
NDC24208-590

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Other strengths and forms

6 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.