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

Purpose

Skin protectant

Description

Dimethicone 5%


Medication Information

Warnings

For external use only

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
Purpose

Skin protectant

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
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

Description

Dimethicone 5%

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.

Active Ingredients

Dimethicone 5%

Question Or Comments?

1 800 876-1261


Structured Label Content

Warnings (WARNINGS)

For external use only

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
Purpose (PURPOSE)

Skin protectant

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
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

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.

Active Ingredients (ACTIVE INGREDIENTS)

Dimethicone 5%

Question Or Comments? (QUESTION OR COMMENTS?)

1 800 876-1261


Advanced Ingredient Data


Raw Label Data

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