Label: RETAINE MGD- mineral oil emulsion
- NDC Code(s): 54799-917-30
- Packager: OCuSOFT, 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 January 12, 2023
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- Active Ingredients
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- KEEP OUT OF THE REACH OF CHILDREN
- Directions
- Other Information
- Inactive ingredients
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- PURPOSE
- PRINCIPAL DISPLAY PANEL - 30 sterile Single-Dose Containers Carton
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INGREDIENTS AND APPEARANCE
RETAINE MGD
mineral oil emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54799-917 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP) LIGHT MINERAL OIL 2 mg in 0.4 mL MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 2 mg in 0.4 mL Inactive Ingredients Ingredient Name Strength CETALKONIUM CHLORIDE (UNII: 85474O1N9D) GLYCERIN (UNII: PDC6A3C0OX) POLOXAMER 188 (UNII: LQA7B6G8JG) TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) TROMETHAMINE (UNII: 023C2WHX2V) TYLOXAPOL (UNII: Y27PUL9H56) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54799-917-30 30 in 1 CONTAINER 01/05/2012 1 0.4 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 01/05/2012 Labeler - OCuSOFT, Inc. (174939207) Registrant - OCuSOFT, Inc. (174939207) Establishment Name Address ID/FEI Business Operations Excelvision 274234566 pack(54799-917) , manufacture(54799-917) Establishment Name Address ID/FEI Business Operations Servipac 571772875 pack(54799-917)