Secura Extra Protective Cream

Secura Extra Protective Cream
SPL v17
SPL
SPL Set ID 499a1944-1682-4798-9058-3748a5eaa420
Route
TOPICAL
Published
Effective Date 2019-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (306.1 mg) Zinc Oxide
Inactive Ingredients
Cellulose Gum Benzethonium Chloride Butylparaben Diazolidinyl Urea Xanthan Gum Methylparaben Mineral Oil Petrolatum Water Alpha-tocopherol Acetate Cetostearyl Alcohol Methyl Glucose Dioleate Karaya Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-08-01
Description

Zinc Oxide 30.6%

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Zinc Oxide 30.6%

Uses
  • skin protectant
  • helps treat and prevent diaper rash
  • protects minor skin irritation associated with diaper rash and helps seal out wetness
Section 50565-1
  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately
Section 50566-9
  • If condition worsensor does not improve within 7 days, contact a doctor
Section 51945-4

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.

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.

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
Active Ingredient

Zinc Oxide 30.6%

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

Update in Line With Otc Monograph

Amendment from reference to 'dermatitis' to 'rash'

Apr 2025

Structured Label Content

Uses (USES)
  • skin protectant
  • helps treat and prevent diaper rash
  • protects minor skin irritation associated with diaper rash and helps seal out wetness
Section 50565-1 (50565-1)
  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately
Section 50566-9 (50566-9)
  • If condition worsensor does not improve within 7 days, contact a doctor
Section 51945-4 (51945-4)

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.

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.

Purpose (PURPOSE)

Skin protectant

Warnings (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 (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
Active Ingredient (ACTIVE INGREDIENT)

Zinc Oxide 30.6%

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (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? (QUESTIONS OR COMMENTS?)

1 800 876-1261

Update in Line With Otc Monograph (Update in line with OTC Monograph)

Amendment from reference to 'dermatitis' to 'rash'

Apr 2025

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:55.678813 · Updated: 2026-03-14T23:08:21.075335