LANTISEPTIC BY DERMARITE ORIGINAL SKIN PROTECTANT- lanolin cream 
Dermarite Industries LLC

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.

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Lantiseptic by Dermarite Moisture Shield Original Skin Protectant

Drug Facts

Active Ingredient

Lanolin USP 50%

Purpose

Skin Protectant

Uses

Warnings

For external use only.

Avoid contact with eyes.

In case of contact, flush thoroughly with water.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Cera Alba, DMDM Hydantoin, Disodium EDTA, Lanolin Alcohol, Mineral Oil, Petrolatum, Sodium borate, Sorbitan Sesquioleate, Water

Questions or Comments?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Package.Label Principal Display Panel

Package.Label Principal Display Panel

LANTISEPTIC BY DERMARITE ORIGINAL SKIN PROTECTANT 
lanolin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN500 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-304-055 g in 1 PACKET; Type 0: Not a Combination Product12/25/2018
2NDC:61924-304-1414.2 g in 1 PACKET; Type 0: Not a Combination Product12/25/2018
3NDC:61924-304-04113 g in 1 TUBE; Type 0: Not a Combination Product12/25/2018
4NDC:61924-304-45130 g in 1 JAR; Type 0: Not a Combination Product12/25/2018
5NDC:61924-304-12340 g in 1 JAR; Type 0: Not a Combination Product12/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/25/2018
Labeler - Dermarite Industries LLC (883925562)

Revised: 1/2020
Document Id: 9c5aefd2-512f-bee0-e053-2995a90a248d
Set id: 773113e9-56ca-5627-e053-2a91aa0a8708
Version: 2
Effective Time: 20200117
 
Dermarite Industries LLC