SENSI CARE BODY CREAM- petrolatum, dimethicone cream

Sensi Care Body Cream by

Drug Labeling and Warnings

Sensi Care Body Cream by is a Otc medication manufactured, distributed, or labeled by Guest Packaging LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

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.

Active ingredients

Petrolatum 30%

Dimethicone 1%

Purpose

Skin Protectant

Inactive ingredients

Water, Glycerin, Cetyl Alcohol, Propylene Glycol Diethylhexanoate, Steareth-2, PVP/Hexadecene Copolymer, Laureth-23, Magnesium Aluminum Silicate, Carbomer, Diazolidinyl Urea, Sodium Hydroxide, Methyl chloroisothiazolinone, Methyl isothiazolinone, Magnesium Chloride, Magnesium Nitrate

STORAGE AND HANDLING

Other information Store at 15°C -30°C (59°F - 86°F)

SPL UNCLASSIFIED SECTION

SENSI-CARE TM

BODY CREAM

- Skin Protectant

- CHG Compatible

- Relieves Chronic Dry Skin

- Fragrance & Dye Free

- Clear In Use

- For All Ages

Manufactured for:
ConvaTec

ConvaTec Inc.
Greensboro, NC 27409
1-800-422-8811
www.convatec.com

Made in USA

Packaging

INGREDIENTS AND APPEARANCE

SENSI CARE BODY CREAM 
petrolatum, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11099-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	25.5 g  in 85 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	850 mg  in 85 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)
STEARETH-2 (UNII: V56DFE46J5)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
LAURETH-23 (UNII: N72LMW566G)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11099-0002-3	85 g in 1 TUBE; Type 0: Not a Combination Product	06/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/09/2016

Labeler - Guest Packaging LLC. (001773076)

Establishment
Name	Address	ID/FEI	Business Operations
Guest Packaging LLC.		001773076	manufacture(11099-0002)