Secura Dimethicone Protectant

Secura Dimethicone Protectant
SPL v10
SPL
SPL Set ID 83f92ac9-4114-4192-926d-be2854a84106
Route
TOPICAL
Published
Effective Date 2015-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (50 mg)
Inactive Ingredients
Hexyl Laurate Isopropyl Palmitate Methylparaben Edetate Disodium Paraffin Petrolatum Propylene Glycol Propylparaben Sodium Chloride Water Yellow Wax Polyglyceryl-4 Isostearate Hydrogenated Castor Oil Cetyl Peg/ppg-10/1 Dimethicone (hlb 5)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2005-08-01 Until 2025-04-20

Description

Dimethicone 5%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 5%

Uses
  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness
  • Temporarily protects and helps relieve chapped or cracked skin and lips
Section 50565-1

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9

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
Section 50567-7

When using this product

  • do not get into eyes
Section 50570-1

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Section 51945-4

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (3.5 g)

Item #59435000

NDC 69740-322-01

Dimethicone Protectant

Skin Protectant

  • Contains 5% Dimethicone
  • For treatment and prevention of incontinence-associated dermatitis
  • Helps prevent and temporarily protect, chafed, chapped, cracked or windburned skin or lips
  • Non-irritating, fragrance-free
  • Pediatric tested
  • CHG Compatible
  • Does not clog briefs

Smith & Nephew

Secura

Dimethicone Protectant

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

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

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - TUBE (114 g)

Item #59432200

NDC 69740-322-00

Dimethicone Protectant

Skin Protectant

  • Contains 5% Dimethicone
  • For treatment and prevention of incontinence-associated dermatitis
  • Helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin or lips
  • Non-irritating, fragrance-free
  • Pediatric tested
  • CHG Compatible
  • Does not clog briefs

Smith & Nephew

Secura

Dimethicone Protectant

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

www.smith-nephew.com

Trademark of Smith & Nephew.

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

Warnings

For external use only

Directions
  • Apply as needed
  • 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, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged
Active Ingredients

Dimethicone 5%

Inactive Ingredients

water, petrolatum, isopropyl palmitate, propylene glycol, cetyl dimethicone copolyol, hexyl laurate, polyglycerol-4 isostearate, sodium chloride, paraffin, hydrogenated castor oil, beeswax, methylparaben, disodium EDTA, propylparaben

Question Or Comments?

1 800 876-1261


Structured Label Content

Uses (USES)
  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness
  • Temporarily protects and helps relieve chapped or cracked skin and lips
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)

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
Section 50567-7 (50567-7)

When using this product

  • do not get into eyes
Section 50570-1 (50570-1)

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Section 51945-4 (51945-4)

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (3.5 g)

Item #59435000

NDC 69740-322-01

Dimethicone Protectant

Skin Protectant

  • Contains 5% Dimethicone
  • For treatment and prevention of incontinence-associated dermatitis
  • Helps prevent and temporarily protect, chafed, chapped, cracked or windburned skin or lips
  • Non-irritating, fragrance-free
  • Pediatric tested
  • CHG Compatible
  • Does not clog briefs

Smith & Nephew

Secura

Dimethicone Protectant

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

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

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - TUBE (114 g)

Item #59432200

NDC 69740-322-00

Dimethicone Protectant

Skin Protectant

  • Contains 5% Dimethicone
  • For treatment and prevention of incontinence-associated dermatitis
  • Helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin or lips
  • Non-irritating, fragrance-free
  • Pediatric tested
  • CHG Compatible
  • Does not clog briefs

Smith & Nephew

Secura

Dimethicone Protectant

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

www.smith-nephew.com

Trademark of Smith & Nephew.

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

Purpose (PURPOSE)

Skin protectant

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)
  • Apply as needed
  • 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, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged
Active Ingredients (ACTIVE INGREDIENTS)

Dimethicone 5%

Inactive Ingredients (INACTIVE INGREDIENTS)

water, petrolatum, isopropyl palmitate, propylene glycol, cetyl dimethicone copolyol, hexyl laurate, polyglycerol-4 isostearate, sodium chloride, paraffin, hydrogenated castor oil, beeswax, methylparaben, disodium EDTA, propylparaben

Question Or Comments? (QUESTION OR COMMENTS?)

1 800 876-1261


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