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.

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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), glycerine, glyceryl monostearate, PEG 100 stearate, stearic acid, ceteareth 20, triethanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, tocopheryl acetate, disodium EDTA

Principal Display Panel - Petroleum Jelly Tube Label

ASSURED™

Vitamin E Enriched

Creamy
PETROLEUM
JELLY

Skin Softener

For Dry Skin

Absorbs Quickly

Compare to active ingredient of
Vaseline
® Deep Moisture™

Net Wt 3 oz (85g)

NDC # 33992-0499-1

Principal Display Panel - Petroleum Jelly Tube Label
PETROLATUM 
petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0499
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)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0499-185 g in 1 TUBE; Type 0: Not a Combination Product02/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/04/2019
Labeler - Greenbrier International, Inc. (610322518)

Revised: 2/2019
Document Id: 41de449c-fada-455f-a565-c8a54589a93c
Set id: b8832ee7-3e13-456b-b301-dad7473a032b
Version: 2
Effective Time: 20190204
 
Greenbrier International, Inc.