Label: KENDALL SOOTHING- zinc oxide ointment

  • 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 April 27, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Zinc oxide 10%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Use

    temporarily protects chapped or cracked skin.

  • WARNINGS

    Warnings

    For external use only.
    When using this product 
    • do not get into eyes
    Do not use on 
    • deep or puncture wounds
    • animal bites
    • serious burns
    Stop use and ask a doctor if
    • condition worsens
    • symptoms last more than seven days or clear up and occur again within a few days.
    Keep out of the reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


  • KEEP OUT OF REACH OF CHILDREN


  • DOSAGE & ADMINISTRATION

    Directions

    • apply as needed
  • SPL UNCLASSIFIED SECTION

    Other Information

    • protect from freezing
    • avoid excessive heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Polysorbate 60, petrolatum, sorbitan stearate, cetyl alcohol, propylene glycol, dimethicone, simmondsia chinensis (jojoba) seed oil, decylene glycol, xanthan gum, cetyl hydroxyethylcellulose, citrus aurantium bergamia (bergamot) fruit oil, citrus medica vulgaris peel oil, retinyl palmitate, tocopheryl acetate, methylparaben, propylparaben, diazolidinyl urea

  • QUESTIONS

    Questions or comments?  1-800-962-9888

  • PRINCIPAL DISPLAY PANEL


    Image of Kendall Soothing Ointment 2 Fl oz Label

    Image of Kendall Soothing Ointment 2 Fl oz Label





  • INGREDIENTS AND APPEARANCE
    KENDALL SOOTHING 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28851-695
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc - UNII:J41CSQ7QDS) Zinc Oxide10 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ACETATE ION (UNII: 569DQM74SC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    1-DECENE (UNII: 7O4U4C718P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28851-695-0159 mL in 1 TUBE
    2NDC:28851-695-02118 mL in 1 TUBE
    3NDC:28851-695-034 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/22/2011
    Labeler - Covidien Inc. (805770828)
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