Label: RETAINE PM- mineral oil, white petrolatum ointment
- NDC Code(s): 54799-893-05
- 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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INGREDIENTS AND APPEARANCE
RETAINE PM
mineral oil, white petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54799-893 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP, Mineral Oil - UNII:T5L8T28FGP) Mineral Oil 200 mg in 1 g Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U, Petrolatum - UNII:4T6H12BN9U) Petrolatum 800 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54799-893-05 5 g in 1 TUBE; Type 0: Not a Combination Product 09/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/02/2013 Labeler - OCuSOFT, Inc. (174939207) Registrant - OCuSOFT, Inc. (174939207) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Private Limited 650970176 manufacture(54799-893)