SECURA PROTECTIVE- zinc oxide cream

Secura Protective by

Drug Labeling and Warnings

Secura Protective 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 10%

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 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, 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, cetearyl alcohol, PEG-40 castor oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, o-phenylphenol, aloe barbadensis

QUESTION OR COMMENTS?

1 800 876-1261

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (50g)

REF 59431100

NDC 69740-311-00

Protective Cream

Skin Protectant

• For treatment and prevention of incontinence-asssociated dermatitis
• Pediatric tested
• CHG compatible
• Enriched with Allantoin, Vitamin E and Aloe
• Clove Oil controls odor
• Conditions and soothes

Smith & Nephew

Secura◊

Protective Cream

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

www.smith-nephew.com

◊Trademark of Smith & Nephew

Certain markes reg’d US Pat. And Tm Off.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (78g)

REF 59431200

NDC 69740-312-00

Protective Cream

Skin Protectant

• For treatment and prevention of incontinence-asssociated dermatitis
• Pediatric tested
• CHG compatible
• Enriched with Allantoin, Vitamin E and Aloe
• Clove Oil controls odor
• Conditions and soothes

Smith & Nephew

Secura◊

Protective Cream

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

www.smith-nephew.com

◊Trademark of Smith & Nephew

Certain markes reg’d US Pat. And Tm Off.

INGREDIENTS AND APPEARANCE

SECURA PROTECTIVE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
CLOVE OIL (UNII: 578389D6D0)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-312-00	78 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 PROTECTIVE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE (UNII: V5VD430YW9)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
CLOVE OIL (UNII: 578389D6D0)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-311-00	50 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)

Registrant - ENCUBE ETHICALS PVT LTD (725076298)

Establishment
Name	Address	ID/FEI	Business Operations
ENCUBE ETHICALS PVT LTD		725076298	MANUFACTURE(69740-311, 69740-312) , analysis(69740-311, 69740-312)