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, Inc., ENCUBE ETHICALS PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

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 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 cream liberally as often as necessary with each diaper, garmet 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

PRINCIPAL DISPLAY PANEL

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

Item #59431100

NDC 50484-311-00

Protective Cream

Skin Protectant

• For treatment and prevention of dermatitis associated with exposure to feces or urine
• Contains Allantoin and Vitamin E
• Clove Oil controls odor
• Conditions and soothes
• Pediatrician tested

Smith & Nephew

Secura◊

Protective Cream

Made in India for:
Smith & Nephew, Inc., St. Petersburg, FL 33716

www.smith-nephew.com

Trademark of Smith & Nephew

Reg. U.S. Pat. & Tm. Off.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SECURA PROTECTIVE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50484-312
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
WATER (UNII: 059QF0KO0R)	597.125 mg  in 1 g
ALLANTOIN (UNII: 344S277G0Z)	2 mg  in 1 g
CLOVE OIL (UNII: 578389D6D0)	2 mg  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T)	3 mg  in 1 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	10 mg  in 1 g
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)	7 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	5 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	150 mg  in 1 g
ALOE VERA FLOWER (UNII: 575DY8C1ER)	0.375 mg  in 1 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	89 mg  in 1 g
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)	14 mg  in 1 g
ETHYLHEXYL PALMITATE (UNII: 2865993309)	8 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50484-312-00	78 g in 1.0 TUBE; Type 0: Not a Combination Product	08/01/2003	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2003	07/31/2020

SECURA PROTECTIVE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50484-311
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)	2 mg  in 1 g
ALOE (UNII: V5VD430YW9)	0.375 mg  in 1 g
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)	7 mg  in 1 g
CLOVE OIL (UNII: 578389D6D0)	2 mg  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T)	3 mg  in 1 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	10 mg  in 1 g
WATER (UNII: 059QF0KO0R)	597.125 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	5 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	150 mg  in 1 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	89 mg  in 1 g
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)	14 mg  in 1 g
ETHYLHEXYL PALMITATE (UNII: 2865993309)	8 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50484-311-00	50 g in 1.0 TUBE; Type 0: Not a Combination Product	08/01/2003	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2003	07/31/2020

Labeler - Smith & Nephew, Inc. (827731451)

Establishment
Name	Address	ID/FEI	Business Operations
ENCUBE ETHICALS PVT LTD		915834105	MANUFACTURE(50484-311, 50484-312)