Label: RESURFIX PLUS- petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 19, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Petrolatum U.S.P

  • Purpose

    Skin protectant

  • Uses

    • A unique dressing formulated to aid in the Skin Barrier healing process. Also provides protection and helps heal stressed skin conditions such as chapped, dry and windburned skin.
  • Warnings

    • Not to be applied over puncture wounds, infections, or lacerations.
    • If condition worsens or does not improve within 7 days, contact a physician.

    • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    • For external use only, not to be swallowed.
    • Avoid contact with eyes.
  • Directions

    • Apply as directed by your physician.
  • Inactive ingredients

    Allantoin, Benzyl Alcohol, Camellia Sinensis (Green Tea) Leaf Extract, Ceramide 2, Ceramide-3, C12-15 Alkyl Benzoate, Ethylhexyl Palmitate, Glycine Soja (Soybean) Seed Extract, Lanolin Alcohol, Mineral Oil, Palmitoyl Oligopeptide, Panthenol, PEG-10 Rapeseed Sterol, Phospholipids, Saccharomyces Lysate Extract, Sorbitan Isostearate, Squalane, Tocopheryl Acetate, Tribehenin, Yucca Glauca Root Extract, Water.

  • PRINCIPAL DISPLAY PANEL - 100 g Tube Label

    REPLENiX®

    RESURFIX+SKIN BARRIER
    HEALING OINTMENT
    SKIN PROTECTANT

    Post Aesthetic • Post Procedure • Post Treatment
    Ceramide 2 & 3 • LYCD
    Green Tea Extract • Squalane NF
    Panthenol • Vitamin E • Allantoin
    Petrolatum USP

    Net wt. 3.5 oz. (100 g.)
    Topix Pharmaceuticals, Inc. • N. Amityville, NY 11701

    PRINCIPAL DISPLAY PANEL - 100 g Tube Label
  • INGREDIENTS AND APPEARANCE
    RESURFIX PLUS 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-884
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM86 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CERAMIDE NP (UNII: 4370DF050B)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-884-03100 g in 1 TUBE; Type 0: Not a Combination Product01/01/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01601/01/2000
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(51326-884)
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