Label: OPTASE- glycerin spray
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- NDC Code(s): 72972-001-01
- Packager: Scope Health Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 30, 2022
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
OPTASE
glycerin sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72972-001 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TROMETHAMINE (UNII: 023C2WHX2V) POTASSIUM CHLORIDE (UNII: 660YQ98I10) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72972-001-01 1 in 1 BOX 04/22/2019 1 17 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M018 04/22/2019 Labeler - Scope Health Inc (116778693) Registrant - Regulatory Matters Consulting (080711165)
