Secura Dimethicone Protectant

Dosage form: cream
Ingredients: DIMETHICONE 50mg in 1g
Labeler: Smith & Nephew, Inc.
NDC Code: 50484-322

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.

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 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.



SECURA DIMETHICONE PROTECTANT 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-322
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM1.7 mg  in 1 g
ISOPROPYL PALMITATE45.1 mg  in 1 g
METHYLPARABEN2 mg  in 1 g
PARAFFIN5 mg  in 1 g
PETROLATUM90 mg  in 1 g
PROPYLENE GLYCOL20 mg  in 1 g
PROPYLPARABEN0.5 mg  in 1 g
SODIUM CHLORIDE8 mg  in 1 g
WATER717.8 mg  in 1 g
BEESWAX0 mg  in 0 g
Packaging
#Item CodePackage Description
1NDC:50484-322-013.5 g in 1.0 PACKET
2NDC:50484-322-00114 g in 1.0 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34708/01/2005
Labeler - Smith & Nephew, Inc. (827731451)
Establishment
NameAddressID/FEIOperations
Swiss-American Products, Inc.611921669MANUFACTURE

Revised: 06/2009
 
Smith & Nephew, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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