DERMACERIN- skin protectant ointment

DermaCerin by

Drug Labeling and Warnings

DermaCerin 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 33%

Purpose:

Skin Protectant

Uses:

• Temporarily protects and helps relieve dry, chapped, or cracked skin.
• Helps protect skin from the drying effects of wind and cold weather.

Warnings:

For external use only.​

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.

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

​Directions:

Apply as needed or as directed by a physician.

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:

Water, Mineral Oil, Paraffin, Lanolin Alcohol, PEG-30 Dipolhydroxystearate, DMDM Hydantoin, Methylparaben, Propylparaben, Propylene Glycol, Sodium Chloride

​Questions?

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

DermaCerin Package Label and Principal Display Panel

INGREDIENTS AND APPEARANCE

DERMACERIN 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	33 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLENE GLYCOL 2-(2-METHYLBUTYRATE) (UNII: 3Z73C506A9)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MINERAL OIL (UNII: T5L8T28FGP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-174-04	106 g in 1 TUBE; Type 0: Not a Combination Product	10/17/2016
2	NDC: 61924-174-08	198 g in 1 TUBE; Type 0: Not a Combination Product	10/17/2016
3	NDC: 61924-174-16	454 g in 1 JAR; Type 0: Not a Combination Product	10/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/17/2016

Labeler - DermaRite Industries, LLC (883925562)

Registrant - DermaRite Industries, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
DermaRite Industries, LLC		883925562	manufacture(61924-174)