SENSI CARE PROTECTIVE BARRIER- petrolatum, zinc oxide cream
ConvaTec Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SENSI-CARE TM PROTECTIVE BARRIER

Active Ingredient

Petrolatum 49%

Zinc Oxide 15%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin and lips.
Helps treat and prevent diaper rash.
Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

For external use only.

Do not use on

deep or puncture wounds
animal bites
serious burns.

When using this product

do not get into eyes.

Stop use and ask doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help or consult a Poison Control Center right away.

Directions

For skin protection

Apply as needed.

For diaper rash

Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
Apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Other Information

Store at 15 oC - 30 oC (59 oF - 86 oF).

Inactive Ingredients

Carboxymethylcellulose Sodium, Water, Stearic Acid, Glycerin, Cetyl Dimethicone Copolyol, Polyglyceryl-4 Isostearate, Hexyl Laurate, Phenoxyethanol.

PRINCIPAL DISPLAY PANEL

SENSI CARE TM

3 PROTECT

PROTECTIVE BARRIER

Skin Protectant
CHG Compatible
Adheres to & Helps Treat Denuded Skin
Easy to Apply & Remove
Fragrance & Dye Free
For All Ages

with 15% Zinc Oxide

Net Wt. 4 oz. (113g)

®/ TM Indicates a trademark

of ConvaTec Inc.

Manufactured for:

ConvaTec

ConvaTec Inc.

Skillman, NJ 08558

1-800-422-8811

www.convatec.com

Made in USA

ProtectiveBarrier113g

SENSI CARE PROTECTIVE BARRIER
petrolatum, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43553-3256
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	490 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43553-3256-4	113 g in 1 TUBE; Type 0: Not a Combination Product	01/05/2000

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/05/2000	07/17/2022

Labeler - ConvaTec Inc. (080128290)

Registrant - ConvaTec Inc. (947989757)

Revised: 11/2020

Document Id: b35a3eac-f935-1e4a-e053-2995a90a3958

Set id: 3efe9523-ee1e-46d6-b79c-e7d74d81baf8

Version: 19

Effective Time: 20201105

ConvaTec Inc.

SENSI-CARE ​TM PROTECTIVE BARRIER