PETROLATUM- petrolatum cream 
Greenbrier International, Inc.

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.

----------

ASSURED™
Drug Facts

Active Ingredient:

White Petrolatum USP (30 %)

Purpose

Skin protectant

Uses

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

Principal Display Panel - 3 oz Tube Label
PETROLATUM 
petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0498
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0498-185 g in 1 TUBE; Type 0: Not a Combination Product05/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/17/2019
Labeler - Greenbrier International, Inc. (610322518)

Revised: 5/2019
Document Id: 04e21867-c530-4c9c-8862-61eb7e51be7d
Set id: 91f24a0c-276f-4962-8da8-462b1f42040e
Version: 1
Effective Time: 20190517
 
Greenbrier International, Inc.