Atropinedrug info
atropine sulfate 10 MG/ML Ophthalmic Solution
What it is used for
1. INDICATIONS AND USAGE Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three months and older for: Atropine is an anticholinergic agent indicated in adults and pediatric patients aged three months and older for: Cycloplegia Mydriasis Penalization of the healthy eye in the treatment of amblyopia 1.1 Cycloplegia 1.2 Mydriasis
1.3 Penalization of the
Healthy Eye in the Treatment of Amblyopia
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 10, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
11. DESCRIPTION Atropine sulfate ophthalmic solution, USP 1% contains atropine an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C 17 H 23 NO 3 ) 2
H 2 SO 4
H 2 O Molecular Weight: 694.84 g/mol Atropine sulfate appears as white or almost white, crystalline powder, or colorless crystals. It is very soluble in water and freely soluble in ethanol (96%). Atropine sulfate ophthalmic solution, USP 1% is a clear, colorless, slightly viscous solution. Each mL of Atropine Sulfate Ophthalmic Solution, USP 1% contains: Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), edetate disodium dihydrate, hypromellose (methocel E4M premium), sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP. Chemical Structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 10, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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