Kendall Soothing
FDA Label NDC 28851-695

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Covidien Inc. for the product Kendall Soothing (NDC 28851-695). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, other, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Zinc oxide 10%

Otc - 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.


Dosage & Administration

Directions

  • apply as needed

Other

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

Otc - Questions

Questions or comments?  1-800-962-9888

Package Label.Principal Display Panel


Image of Kendall Soothing Ointment 2 Fl oz Label





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