LANODERM- otc skin protectant drug products ointment

Lanoderm by

Drug Labeling and Warnings

Lanoderm by is a Otc medication manufactured, distributed, or labeled by Dermarite Industries LLC, 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 punctured wounds.
• Stop use and ask doctor if condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.

Warnings:

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

Directions:

Apply liberally to affected area as needed or as directed by 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:

Cera Alba, Disodium EDTA, DMDM Hydantion, Lanolin Alcohol, Methylparaben, Mineral Oil, PEG-30 Dipolyhydroxydstearate, Petrolatum, Propylene Glycol, Propylparaben, Sodium Borate, Sodium Chloride, Water

Questions?

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

Lanoderm Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

LANODERM 
otc skin protectant drug products ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
WHITE WAX (UNII: 7G1J5DA97F)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-232-04	113 g in 1 TUBE; Type 0: Not a Combination Product	04/16/2012
2	NDC: 61924-232-05	5 g in 1 PACKET; Type 0: Not a Combination Product	04/16/2012
3	NDC: 61924-232-15	15 g in 1 PACKET; Type 0: Not a Combination Product	04/16/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/16/2012

Labeler - Dermarite Industries LLC (883925562)

Registrant - DermaRite Industries, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
Dermarite Industries LLC		883925562	manufacture(61924-232)