Label: EIGHT HOUR SKIN FRAGRANCE FREE- 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.

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Updated February 9, 2022

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  • ACTIVE INGREDIENT

    PETROLATUM 56.8%

  • INACTIVE INGREDIENTS

    LANOLIN, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINÉRALE, ACACIA DECURRENS EXTRACT, DIPTERYX ODORATA BEAN EXTRACT, VANILLIN, TOCOPHEROL, TOCOPHERYL ACETATE, BHT, SALICYLIC ACID, RICINUS COMMUNIS (CASTOR) SEED OIL, VEGETABLE OIL/OLUS/HUILE VÉGÉTALE, ZEA MAYS (CORN) OIL, BENZYL ALCOHOL, IRON OXIDES

  • USES

    Treats symptoms of:

    • chapping
    • peeling or flaking due to minor burns
    • sunburn
    • windburn
    • scrapes
    • abrasions
    • cracked lips
  • WARNINGS

    • For external use only

    When using this product

    • Avoid contact with eyes
    • Do not apply over puncture wounds, infections or lacerations

    Stop using and ask a doctor if

    • Symptoms persist more than 7 days
  • DIRECTIONS

    Apply liberally as often as necessary

  • CARTON ART

    8HR FF

  • INGREDIENTS AND APPEARANCE
    EIGHT HOUR SKIN FRAGRANCE FREE 
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-673
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM56.8 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ACACIA DECURRENS WHOLE (UNII: 8KZ75S2VSK)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CORN OIL (UNII: 8470G57WFM)  
    DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)  
    VANILLIN (UNII: CHI530446X)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LANOLIN (UNII: 7EV65EAW6H)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-673-1750 g in 1 TUBE; Type 0: Not a Combination Product04/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/15/2013
    Labeler - REVLON (788820165)
    Registrant - REVLON (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Essence, LLC dba Voyant Beauty032565959manufacture(10967-673)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab. INC.080987545manufacture(10967-673)
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