DERMAPHOR- 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 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.

Authorization status:

OTC monograph final

Summary of Product characteristics

DERMAPHOR- 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._
----------
DERMAPHOR
ACTIVE INGREDIENT:
Petrolatum 44.28%
PURPOS E:
Skin Protectant
US ES :
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
QUES TIONS ?:
Call 800-337-6296 Mon - Fri 9AM - 5PM EST.
DERMAPHOR PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL
DERMAPHOR
skin protectant ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 19 24-18 4
ROUTE OF ADMINISTRATION
TOPICAL
DermaRite Industries, LLC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)
PETROLATUM
44 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
MINERAL O IL (UNII: T5L8 T28 FGP)
LANO LIN ALCO HO LS (UNII: 8 8 4C3FA9 HE)
PARAFFIN (UNII: I9 O0 E3H2ZE)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 19 24-18 4-0 4
10 6 g in 1 TUBE; Type 0 : No t a Co