LANTISEPTIC BY DERMARITE DRY SKIN THERAPY- lanolin cream

Lantiseptic by Dermarite Dry Skin Therapy by

Drug Labeling and Warnings

Lantiseptic by Dermarite Dry Skin Therapy by is a Otc medication manufactured, distributed, or labeled by Dermarite Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Do not use on
• Deep or puncture wounds
• animal bites
• serious burns

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 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:

INGREDIENTS AND APPEARANCE

LANTISEPTIC BY DERMARITE DRY SKIN THERAPY 
lanolin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-504
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-504-14	14.2 g in 1 PACKET; Type 0: Not a Combination Product	12/25/2018
2	NDC: 61924-504-04	113 g in 1 TUBE; Type 0: Not a Combination Product	12/25/2018
3	NDC: 61924-504-05	5 g in 1 PACKET; 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)

Registrant - Dermarite Industries LLC (883925562)