SENSI CARE MOISTURIZING BODY- petrolatum cream

SENSI CARE MOISTURIZING BODY by

Drug Labeling and Warnings

SENSI CARE MOISTURIZING BODY by is a Otc medication manufactured, distributed, or labeled by ConvaTec, Inc., Guest Packaging LLC, Medicia. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Petrolatum 30%

Dimethicone 1%

Purpose

Skin Protectant

Skin Protectant

Uses

• Temporarily protects minor
• cuts
• scrapes
• burns.

• 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 a 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 cream 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 15oC - 30oC (59oF - 86oF).

Inactive Ingredients

Water, Glycerin, PG Dioctanoate, Cetyl Alcohol, Steareth-2, PVP/Hexadecene Copolymer, Laureth-23, Magnesium Aluminum Silicate, Diazolidinyl Urea, Carbomer, Sodium Hydroxide, Magnesium Nitrate, Methylchloroisothiazolinone and Methylisothiazolinone.

PRINCIPAL DISPLAY PANEL

NDC: 43553-3244-3

ConvaTec

SENSI~CARETM

Moisturizing Body Cream 2

MOISTURIZE

SKIN PROTECTANT

Relieves Chronic Dry Skin

Fragrance Free

NET WT. 3oz.(85g)

CSX1083B  Case Order No. 324403

INGREDIENTS AND APPEARANCE

SENSI CARE MOISTURIZING BODY 
petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43553-3244
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	300 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARETH-2 (UNII: V56DFE46J5)
LAURETH-23 (UNII: N72LMW566G)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CARBOMER 934 (UNII: Z135WT9208)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Product Characteristics
Color	white (white to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43553-3244-3	85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/15/1998

Labeler - ConvaTec, Inc. (947989757)

Registrant - ConvaTec, Inc. (947989757)

Establishment
Name	Address	ID/FEI	Business Operations
Guest Packaging LLC		001773076	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Medicia		091396697	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
ConvaTec, Inc.		947989757	analysis