Label: VASELINE INTENSIVE CARE DEEP MOISTURE- petroleum 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 December 6, 2022

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  • ACTIVE INGREDIENT

    Active ingredient

    WHITE PETROLATUM USP (30%)

  • PURPOSE

    Purpose

    skin protectant

  • INDICATIONS & USAGE

    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

    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 within 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.

  • DOSAGE & ADMINISTRATION

    Directions apply as needed.

  • INACTIVE INGREDIENT

    Inactive ingredients  Water (Aqua), Caprylic/Capric Triglyceride, Stearic Acid, Glycerin, Sodium Hydroxypropyl Starch Phosphate, Glycol Stearate, PEG-100 Stearate, Glyceryl Stearate, Cetyl Alcohol, Phenoxyethanol, Methylparaben, Isopropyl Myristate, Propylparaben, Stearamide AMP, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Potassium Hydroxide, Cedrol, Tocopheryl Acetate, Titanium Dioxide (CI 77891).

  • QUESTIONS

    Questions? Call 1-800-457-7084

  • 4.5 oz PDP

    VICDeepMoisturePDP

  • INGREDIENTS AND APPEARANCE
    VASELINE  INTENSIVE CARE DEEP MOISTURE
    petroleum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1401
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARAMIDE AMP (UNII: U3K8640346)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CEDROL (UNII: 63ZM9703BO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1401-1127 g in 1 TUBE; Type 0: Not a Combination Product10/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2015
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Manufacturing (US), Inc.021679448manufacture(64942-1401)
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