Petrolatum by Greenbrier International, Inc. PETROLATUM cream

Petrolatum by

Drug Labeling and Warnings

Petrolatum by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

White Petrolatum USP (30 %)

Purpose

Skin protectant

Uses

• temporarily protects minor:
  • cuts
  • scrapes
  • burns
• temporarily protects and helps relieve chapped or cracked skin
• helps protect from the drying effects of wind and cold weather

Warnings

For external use only.

Do not use on deep puncture wounds, animal bites and serious burns.

When using this product,

do not get into eyes

Stop use and ask doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as needed.

Inactive ingredients

water (aqua), glycerin, glyceryl monostearate, PEG-100 stearate, stearic acid, ceteareth 20, trieathanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA

110781 DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

MADE IN INDIA

Skin Softener

Hydrates &

Evens Skin Tone

COCOA

BUTTER

Petroleum Jelly

C. No. DNH/COS/DNH/130

1222101976

Principal Display Panel - 3 oz Tube Label

ASSURED™

Vitamin E Enriched

Creamy

COCOA
BUTTER

Petroleum Jelly

Skin Softener

Hydrates &
Evens Skin Tone

Net Wt 3 oz (85g)

NDC # 33992-0498-1

INGREDIENTS AND APPEARANCE

PETROLATUM 
petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-0498
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
TROLAMINE (UNII: 9O3K93S3TK)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-0498-1	85 g in 1 TUBE; Type 0: Not a Combination Product	05/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/17/2019

Labeler - Greenbrier International, Inc. (610322518)