Label: OPTASE- white petrolatum, lanolin ointment
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- NDC Code(s): 72972-003-01
- 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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INGREDIENTS AND APPEARANCE
OPTASE
white petrolatum, lanolin ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72972-003 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 0.9 g in 1 g LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 0.06 g in 1 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72972-003-01 1 in 1 BOX 05/05/2021 1 5 g in 1 TUBE; 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 05/05/2021 Labeler - Scope Health Inc (116778693) Registrant - Regulatory Matters Consulting (080711165)
