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 appliedover deep or puncture wounds, infections, or lacerations

If condition worsensor 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 59 oF-86 oF (15 oC-30 oC)

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

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.

92grams-secura-label

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

Item #59432500

NDC69740-325-00

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.

219grams-secura-label

SECURA EXTRA PROTECTIVE
zinc oxide cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	08/01/2003

Labeler - Smith & Nephew Medical Ltd (216344051)

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

Secura Extra Protective Cream

DRUG FACTS

ACTIVE INGREDIENT

PURPOSE

USES

WARNINGS

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

QUESTIONS OR COMMENTS?