LANTISEPTIC BY DERMARITE DRY SKIN THERAPY- 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 Dry Skin Therapy

Active Ingredient

Lanolin USP 30%

Purpose

Skin Protectant

Uses

Temporarily protects minor cuts, scrapes, and burns.

Helps prevent and temporarily protects chafed, chapped or cracked skin.

Warnings

For external use only.

Avoid contact with eyes. In case of contact, flush thoroughly with water

Stop use and ask a doctor if

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

Keep out of reach of children.

Directions

Apply liberally to affected area as needed or as directed by a physician.

Other Information

Store at room temperature (59-86°F)

You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.

Inactive Ingredients

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

Questions or Comments?

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

Package Labeling:

principal display panel

LANTISEPTIC BY DERMARITE DRY SKIN THERAPY 
lanolin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-504
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-504-1414.2 g in 1 PACKET; Type 0: Not a Combination Product12/25/2018
2NDC:61924-504-04113 g in 1 TUBE; Type 0: Not a Combination Product12/25/2018
3NDC:61924-504-055 g in 1 PACKET; 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)
Registrant - Dermarite Industries LLC (883925562)

Revised: 1/2020
Document Id: 9c5b13c9-23e5-bcdc-e053-2995a90a1d4e
Set id: 7730af3b-fea2-63ee-e053-2991aa0afe0c
Version: 2
Effective Time: 20200117
 
Dermarite Industries LLC