Label: SKIN-LUBE- alcohol ointment
- NDC Code(s): 59316-995-21, 59316-995-95, 59316-995-96, 59316-995-97
- Packager: Performance Health, LLC
- 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 August 7, 2022
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- Package Labeling: 59316-995-95
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INGREDIENTS AND APPEARANCE
SKIN-LUBE
alcohol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-995 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 850 mg in 1 g DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 15 mg in 1 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) ZINC STEARATE (UNII: H92E6QA4FV) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-995-21 78 g in 1 JAR; Type 0: Not a Combination Product 05/18/2017 12/31/2024 2 NDC:59316-995-95 11340 g in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2017 12/31/2024 3 NDC:59316-995-96 454 g in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2017 12/31/2024 4 NDC:59316-995-97 2270 g in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2017 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/18/2017 12/31/2024 Labeler - Performance Health, LLC (794324061)