Secura Extra Protective Cream
FDA Label NDC 69740-325

10 label sections · Submitted to the FDA by Smith & Nephew Medical Ltd · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Smith & Nephew Medical Ltd for the product Secura Extra Protective Cream (NDC 69740-325). 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 active ingredient, purpose, uses, update in line with otc monograph, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 30.6%

Purpose

Skin protectant

Uses

  • skin protectant
  • helps treat and prevent diaper rash
  • protects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

  • For external use only
  • Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clears up and occur again within a few days
  • When using this product do not get into eyes
  • Not to be applied over deep or puncture wounds, infections, or lacerations
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Certer immediately

Directions

  • change wet and soiled diapers, garments and linens promptly
  • cleanse the affected area and allow to dry
  • apply cream liberally as often as necessary with each diaper change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

Other Information

Store at controlled room temperature 59 oF-86 oF (15 oC-30 oC)

Inactive Ingredients

benzethonium chloride, butylparaben, cellulose gum, cetearyl alcohol, diazolidinyl urea, methyl glucose dioleate, methylparaben, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum.

Questions Or Comments?

1 800 876-1261

Package Label.Principal Display Panel

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (92g)

Item #59432400

NDC 69740-324-00

Extra Protective Cream

Skin Protectant

  • For treatment and prevention of incontinence-associated dermatitis
  • For use on denuded skin associated with exposure to feces or urine
  • Adheres to macerated skin
  • Pediatric tested
  • CHG compatible

    • Smith & Nephew

    Secura ◊

    Extra Protective Cream

    Made in India for
    Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England

    ◊Trademark of Smith & Nephew

    Certain marks reg'd U.S. Pat. and Tm. Off.

    69740-324-00 (69740 324 00)

    69740-324-00 (69740 324 00)

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (219g)

    Item #59432500

    NDC69740-325-00

    Extra Protective Cream

    Skin Protectant

    • For treatment and prevention of incontinence-associated dermatitis
    • For use on denuded skin associated with exposure to feces or urine
    • Adheres to macerated skin
    • Pediatric tested
    • CHG compatible


      • Smith & Nephew

      Secura◊

      Extra Protective Cream

      Made in India for
      Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England

      ◊Trademark of Smith & Nephew

      Certain marks reg'd U.S. Pat. and Tm. Off.

      219grams-secura-label (219g Secura)

      219grams-secura-label (219g Secura)

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