SECURA DIMETHICONE PROTECTANT- dimethicone cream 
Smith & Nephew, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Secura Dimethicone Protectant

DRUG FACTS

ACTIVE INGREDIENTS

Dimethicone 5%

PURPOSE

Skin protectant

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

WARNINGS

For external use only

When using this product

  •  do not get into eyes

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

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

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

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

QUESTION OR COMMENTS?

1 800 876-1261


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

Item #59435000

NDC 50484-322-01

Dimethicone Protectant


Skin Protectant

  • Contains 5% Dimethicone
  • For treatment and prevention of diaper dermatitis associated with exposure to feces or urine
  • Does not clog briefs
  • Non-irritating, fragrance-free
  • Pediatrician tested

Smith & Nephew

Secura

Dimethicone Protectant


Manufactured by:
Smith & Nephew, Inc., Largo, FL 33773

Trademark of Smith & Nephew. Reg. U.S. Pat. & Tm. Off.


Package Display - Tube (3.5g)


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

Item #59432200

NDC 50484-322-00

Dimethicone Protectant


Skin Protectant

  • Contains 5% Dimethicone
  • For treatment and prevention of diaper dermatitis associated with exposure to feces or urine
  • Help prevent and temporarily protect chafied, chapped, cracked, or windburned skin or lips
  • Non-irritating, fragrance-free
  • Does not clog briefs
  • Pediatrician tested

Smith & Nephew

Secura

Dimethicone Protectant


Manufactured by:
Smith & Nephew, Inc., Largo, FL 33773

www.smith-nephew.com

Trademark of Smith & Nephew.

Reg. U.S. Pat. & Tm. Off.


Package Display - Tube 114g


SECURA DIMETHICONE PROTECTANT 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-322
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50484-322-013.5 g in 1.0 PACKET; Type 0: Not a Combination Product08/01/200507/31/2018
2NDC:50484-322-00114 g in 1.0 TUBE; Type 0: Not a Combination Product08/01/200507/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/200507/31/2018
Labeler - Smith & Nephew, Inc. (827731451)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933MANUFACTURE(50484-322)

Revised: 7/2016
 
Smith & Nephew, Inc.