SECURA EXTRA PROTECTIVE- zinc oxide cream SECURA EXTRA PROTECTIVE CREAM- zinc oxide cream

Secura Extra Protective Cream by

Drug Labeling and Warnings

Secura Extra Protective Cream by is a Otc medication manufactured, distributed, or labeled by Smith & Nephew Medical Ltd, ENCUBE ETHICALS PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Zinc Oxide 30.6%

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 Certer immediately

• Avoid contact with 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 cream liberally as often as necessary with each diaper change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

OTHER INFORMATION

Store at controlled room temperature 59oF-86oF (15oC-30oC)

INACTIVE INGREDIENTS

petrolatum, karaya gum, cetearyl alcohol, methyl glucose dioleate, mineral oil, cellulose gum, water, methylparaben, tocopheryl acetate, diazolidinyl urea, benzethonium chloride, butylparaben

QUESTIONS OR COMMENTS?

1 800 876-1261

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (92g)

Item #59432400

NDC 69740-324-00

Extra Protective Cream

Skin Protectant

• For treatment and prevention of incontinence-associated dermatitis
• For use on denuded skin associated with exposure to feces or urine
• Adheres to macerated skin
• Pediatric tested
• CHG compatible

Smith & Nephew

Secura◊

Extra Protective Cream

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

◊Trademark of Smith & Nephew

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

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (219g)

Item #59432500

NDC 69740-325-00

Extra Protective Cream

Skin Protectant

• For treatment and prevention of incontinence-associated dermatitis
• For use on denuded skin associated with exposure to feces or urine
• Adheres to macerated skin
• Pediatric tested
• CHG compatible

Smith & Nephew

Secura◊

Extra Protective Cream

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

◊Trademark of Smith & Nephew

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

INGREDIENTS AND APPEARANCE

SECURA EXTRA PROTECTIVE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-324
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	306.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)	30.6 mg  in 1 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744)	1.3 mg  in 1 g
BUTYLPARABEN (UNII: 3QPI1U3FV8)	0.5 mg  in 1 g
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	2 mg  in 1 g
KARAYA GUM (UNII: 73W9IQY50Q)	71.4 mg  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T)	3.1 mg  in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	41 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	408.2 mg  in 1 g
WATER (UNII: 059QF0KO0R)	21.6 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	2 mg  in 1 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	61.2 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-324-00	92 g in 1.0 TUBE; Type 0: Not a Combination Product	08/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2003

SECURA EXTRA PROTECTIVE CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-325
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	306.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)	30.6 mg  in 1 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744)	1.3 mg  in 1 g
BUTYLPARABEN (UNII: 3QPI1U3FV8)	0.5 mg  in 1 g
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	2 mg  in 1 g
KARAYA GUM (UNII: 73W9IQY50Q)	71.4 mg  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T)	3.1 mg  in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	41 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	408.2 mg  in 1 g
WATER (UNII: 059QF0KO0R)	21.6 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	2 mg  in 1 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	61.2 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-325-00	219 g in 1.0 TUBE; Type 0: Not a Combination Product	08/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2003

Labeler - Smith & Nephew Medical Ltd (216344051)

Establishment
Name	Address	ID/FEI	Business Operations
ENCUBE ETHICALS PVT LTD		725076298	MANUFACTURE(69740-324, 69740-325)