DERMACERIN- skin protectant ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

Available from:

DermaRite Industries, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

DERMACERIN- SKIN PROTECTANT OINTMENT
DERMARITE INDUSTRIES, LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
DERMACERIN
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
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