Label: PERSONAL CARE VITAMIN E- white petrolatum cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 2, 2018

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Petrolatum (30%)

  • Purpose

    Skin protectant

  • Uses

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

  • Warnings

    For external use only

  • When using this product

    do not get into eyes

  • Stop use and ask a doctor if

    ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days

  • Do not use on

    ■ deep or puncture wounds ■ animal bites ■ serious burns

  • 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), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, stearyl alcohol, glyceryl stearate, fragrance, ploysorbate-80, laureth-20, BHT, methyparaben,propylparaben, dimethicone, tocopherol

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE  VITAMIN E
    white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-120
    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
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LAURETH-20 (UNII: 6SU0SC83AH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-120-45128 g in 1 TUBE; Type 0: Not a Combination Product04/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/09/2018
    Labeler - Delta Brands & Products LLC (080999173)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!