Label: DR. BUTLER SOOTHING INCONTINENCE- petrolatum 36% spray

  • Category: HUMAN OTC DRUG LABEL

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 23, 2021

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  • ACTIVE INGREDIENT

    Petrolatum 36%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Temporarily protects and helps relieve chafed, chapped, or cracked skin.

  • WARNINGS

    For external use only.

    Do not use on deep or puncture wounds.

    When using this product avoid contact in eyes, rinse with water to remove, contents under pressure, do not puncture or incinerate, do not store at temperatures above 120F.

    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.

    Ask a healthcare or professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, seek medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Shake well. Hold 4-6 inches from the skin and apply a thin continuous coating. Apply as needed.

  • INACTIVE INGREDIENT

    4-t-Butylcyclohexanol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, Mineral Oil, Pentylene Glycol, PPG-15 Stearyl Ether.

  • PRINCIPAL DISPLAY PANEL

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    DR. BUTLER SOOTHING INCONTINENCE 
    petrolatum 36% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL59.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    ALOE (UNII: V5VD430YW9)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70942-017-0385 g in 1 CAN; Type 0: Not a Combination Product07/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/26/2021
    Labeler - Beyond Health P.A. (026781064)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(70942-017)
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