LANTISEPTIC BY DERMARITE ORIGINAL SKIN PROTECTANT- lanolin cream

Lantiseptic by DermaRite Original Skin Protectant by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredient

Lanolin USP 50%

Purpose

Skin Protectant

Uses

• Helps relieve and prevent rashes and irritation due to wetness from incontinence.
• Protects chafed skin due to irritation and helps seal out wetness.

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

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

Directions

• Cleanse and remove any urine or fecal matter from area; pat dry.
• Apply generously to affected area as neeeded, especially after incontinence episodes.
• Repeat after each incontinent episode or as needed.

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

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

INGREDIENTS AND APPEARANCE

LANTISEPTIC BY DERMARITE ORIGINAL SKIN PROTECTANT 
lanolin cream

Product 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)