SENSI CARE INCONTINENCE WIPES- dimethicone cloth

Sensi Care Incontinence Wipes by

Drug Labeling and Warnings

Sensi Care Incontinence Wipes by is a Otc medication manufactured, distributed, or labeled by ConvaTec Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Dimethicone 3%

Purpose

Skin Protectant

Uses

• Temporarily protects chapped or cracked skin 
• Helps to protect skin from irritations associated with incontinence episodes 
• Helps to treat and prevent perineal dermatitis

Warnings

 For external use only  Avoid contact with eyes

Do  not use on

 deep or puncture wounds  animal bites  serious burns

Stop use and consult a doctor if

condition worsens  sysmptoms last more than 7 days or clear up and occur again after a few days

Keep out of reach of children

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

Directions

 Open package as directed  Remove cloths one at a time  Cleanse soiled areas Use textured side for heavily soiled areas  Apply as needed  Reseal package label between uses  DO NOT FLUSH  Discard cloth in waste receptacle  For single patient use only

Other information

This product may be used at room temperature or warmed  To warm, partially peel the label back and microwave  Microwave oven wattage varies, therefore adjust time as required  DO NOT USE HOT  Test with ungloved hand as gloves may diminish sensitivity to heat  DO not use until product has cooled to ensure patient comfort and avoid injury  Do not reheat once product has been opened  Cloth made of 100% Viscose

Store at 15°C-25°C (59°F-77°F)

Inactive ingredients

Water, Coco-Glucoside, Ethylhexylglycerin, Methylparaben, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylparaben, Tetra Sodium EDTA

Package Labeling:

INGREDIENTS AND APPEARANCE

SENSI CARE INCONTINENCE WIPES 
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43553-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO GLUCOSIDE (UNII: ICS790225B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ETHYLPARABEN (UNII: 14255EXE39)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43553-1000-1	8 in 1 POUCH	10/19/2016
1		0.3 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/19/2016

Labeler - ConvaTec Inc. (080128290)