SECURA PROTECTIVE- petrolatum ointment

Secura Protective by

Drug Labeling and Warnings

Secura Protective by is a Otc medication manufactured, distributed, or labeled by Smith & Nephew Medical Ltd, Swiss-American CDMO LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, cholecalciferold, D&C Green #6

QUESTIONS OR COMMENTS?

1 800 876-1261

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (3.5 g)

#59434800

NDC-69740-315-01

Protective Ointment

Skin Protectant

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

Smith&Nephew 

Secura◊

Protective Ointment

Net wt. 0.12 oz (3.5 g)

Made in the USA for:

Smith & Nephew Medical Ltd,

101 Hessle Road, Hull, HU3 2BN, England

Trademark of Smith & Nephew. Certain marks Reg'd U.S. Pat. & Tm. Off.

INGREDIENTS AND APPEARANCE

SECURA PROTECTIVE 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69740-315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	987.89 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	5 mg  in 1 g
CLOVE OIL (UNII: 578389D6D0)	3 mg  in 1 g
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)	0.01 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	2 mg  in 1 g
CHOLECALCIFEROL (UNII: 1C6V77QF41)	0.1 mg  in 1 g
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69740-315-01	3.5 g in 1 POUCH; 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
Swiss-American CDMO LLC		080170933	MANUFACTURE(69740-315)