Label: LANTISEPTIC BY DERMARITE ORIGINAL SKIN PROTECTANT- lanolin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61924-304-04, 61924-304-05, 61924-304-12, 61924-304-14, view more61924-304-45 - Packager: Dermarite Industries 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 January 17, 2020
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INGREDIENTS AND APPEARANCE
LANTISEPTIC BY DERMARITE ORIGINAL SKIN PROTECTANT
lanolin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61924-304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 500 mg in 1 g Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) WHITE WAX (UNII: 7G1J5DA97F) EDETATE DISODIUM (UNII: 7FLD91C86K) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61924-304-05 5 g in 1 PACKET; Type 0: Not a Combination Product 12/25/2018 2 NDC:61924-304-14 14.2 g in 1 PACKET; Type 0: Not a Combination Product 12/25/2018 3 NDC:61924-304-04 113 g in 1 TUBE; Type 0: Not a Combination Product 12/25/2018 4 NDC:61924-304-45 130 g in 1 JAR; Type 0: Not a Combination Product 12/25/2018 5 NDC:61924-304-12 340 g in 1 JAR; Type 0: Not a Combination Product 12/25/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/25/2018 Labeler - Dermarite Industries LLC (883925562)