Your browser does not support JavaScript! SECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW, INC.]
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SECURA PROTECTIVE (petrolatum) ointment
[Smith & Nephew, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

DRUG FACTS

ACTIVE INGREDIENTS

Petrolatum 98.789%

PURPOSE

Skin protectant

USES

  • Skin protectant
  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

WARNINGS

  • For external use only
  • Avoid contact with the eyes  

  • Not to be applied over deep or puncture wounds, infections or lacerations 

  • If condition worsens or does not improve within 7 days, contact a doctor 

  • Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately 

DIRECTIONS

  • change wet and soiled diapers, garments and linens promptly
  • cleanse the affected area and allow to dry
  • apply ointment 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

benzyl alcohol, clove oil, o-phenylphenol, tocopheryl acetate, corn oil, retinyl palmitate, cholecalciferol, D&C Green #6

QUESTIONS OR COMMENTS?

1 800 876-1261

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (70g)

#59431500
NDC 50484-315-00

Protective Ointment

Skin Protectant

  • For treatment and prevention of diaper dermatitis associated with exposure to feces or urine
  • Contains Vitamins A, D & E
  • Clove Oil controls odor
  • Pediatrician tested

Smith&Nephew
Secura
Protective Ointment

Net  wt. 2.47 oz (70g)


Made in India for:
Smith & Nephew, Inc., St. Petersburg, FL 33716
Trademark of Smith & Nephew. Reg. U.S. Pat. & Tm. Off.

Package Display - Protective Ointment (3.5g)


SECURA PROTECTIVE 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50484-315
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM987.89 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL5 mg  in 1 g
CLOVE OIL3 mg  in 1 g
D&C GREEN NO. 60.01 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE2 mg  in 1 g
CHOLECALCIFEROL0.1 mg  in 1 g
VITAMIN A PALMITATE 
CORN OIL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50484-315-0070 g in 1.0 TUBE
2NDC:50484-315-01150 in 1 BOX
23.5 g in 1.0 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34708/01/2003
SECURA PROTECTIVE 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50484-316
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM987.89 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL5 mg  in 1 g
CLOVE OIL3 mg  in 1 g
D&C GREEN NO. 60.01 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE2 mg  in 1 g
CHOLECALCIFEROL0.1 mg  in 1 g
VITAMIN A PALMITATE 
CORN OIL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50484-316-00159 g in 1.0 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34708/01/2003
Labeler - Smith & Nephew, Inc. (827731451)
Registrant - ENCUBE ETHICALS PVT LTD (915834105)
Establishment
NameAddressID/FEIBusiness Operations
ENCUBE ETHICALS PVT LTD915834105MANUFACTURE

Revised: 5/2010
 
Smith & Nephew, Inc.

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