DERMASEPTIN- otc skin protectant drug products ointment

DERMASEPTIN by

Drug Labeling and Warnings

DERMASEPTIN by is a Otc medication manufactured, distributed, or labeled by DermaRite Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

• Zinc Oxide 19%
• Calamine 2%

Purpose:

• Zinc Oxide: Skin protectant
• Calamine : Skin protectant

Uses:

Dries the oozing and weeping of poison:

• Ivy
• Oak
• Sumac
• Or othe skin irritations

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.

Warnings:

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

Directions

Applied as needed.

Other Information:

Store at room temperature (59°-86°F).

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

Inactive Ingredients:

Petrolatum, Lanolin, Glycerin, Menthol, Sodium Bicarbonate, methylparaben, Propylparaben

Questions

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

Dermaseptin Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

DERMASEPTIN 
otc skin protectant drug products ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	2.3 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21.47 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
PETROLATUM (UNII: 4T6H12BN9U)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-210-05	5 g in 1 PACKET; Type 0: Not a Combination Product	10/25/2010
2	NDC: 61924-210-04	113 g in 1 TUBE; Type 0: Not a Combination Product	10/25/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/25/2010

Labeler - DermaRite Industries, LLC (883925562)

Registrant - DermaRite Industries, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
DermaRite Industries, LLC		883925562	manufacture(61924-210)