DERMAPHOR- skin protectant ointment

Dermaphor by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient:

Petrolatum 44.28%

Purpose:

Skin Protectant

Uses:

• Temporarily protects minor cuts, scrapes, burns.
• Temporarily protects and helps relieve chapped or cracked skin and lips.
• Helps protect skin from the drying effects of wind and cold weather.

Warnings:

​For external use only.

Warnings:

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

Warnings:

Stop and ask a doctor if

• condition worsens
• ​symptoms last more than 7 days or clear up and occur again within a few days

​Warnings:

Do not use ​on deep or puncture wounds, animal bites, or serious wounds.

​Warnings:

Keep out of reach of children.

​Incase of accidental ingestion contact a Physician or Poison Control Center right away.

Directions:

Apply liberally to affected area as needed.

Other Information:

• Store at room temperature (59º- 86ºF)
• You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.

Inactive Ingredients:

Mineral Oil, Paraffin, Lanolin Alcohol

Questions?:

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

DermaPhor Package Label and Principal Display Panel

INGREDIENTS AND APPEARANCE

DERMAPHOR 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	44 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-184-04	106 g in 1 TUBE; Type 0: Not a Combination Product	11/17/2016
2	NDC: 61924-184-08	198 g in 1 TUBE; Type 0: Not a Combination Product	11/17/2016
3	NDC: 61924-184-16	454 g in 1 JAR; Type 0: Not a Combination Product	11/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/17/2016

Labeler - DermaRite Industries, LLC (883925562)

Registrant - DermaRite Industries, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
DermaRite Industries, LLC		883925562	manufacture(61924-184)