COMFORT SHIELD BARRIER- dimethicone cloth

Comfort Shield Barrier by

Drug Labeling and Warnings

Comfort Shield Barrier by is a Otc medication manufactured, distributed, or labeled by Sage Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Dimethicone 3%

Purpose

Skin protectant

Uses

• helps seal out wetness
• helps treat and prevent perineal dermatitis
• protects from minor skin irritation associated with perineal dermatitis
  

Warnings

For external perineal use only. 
Avoid contact with the eyes.

Stop use and consult a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children.

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

Directions

• remove wet and soiled garment
• cleanse soiled area using a fresh barrier cream cloth
• discard cloth after use - DO NOT FLUSH CLOTHS
• use as often as necessary, especially if prolonged exposure to wetness is anticipated
• for individual use only
• reseal label between uses
• discard package immediately if cloths are dry

If warming is desired:

• peel open label without completely removing it
• heat entire package in microwave no longer than [see package for time].
• since microwave wattage varies, adjust heating time accordingly
• Comfort Shield® may also be used at room temperature or warmed in a Comfort Personal Cleansing Warmer.
• Caution: If there is any indication barrier cloths are excessively hot, do not use
• Remember, gloves diminish your sensitivity to heat
• Closely monitor heat level with infants, unresponsive or skin sensitive individuals

Inactive Ingredients

Water, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, cetyl alcohol, glycerin, stearyl alcohol, phenoxyethanol, methylpropanediol, chlorhexidine gluconate, hydroxyethyl cellulose, ethylhexylglycerin, polyquaternium-37, propylene glycol dicaprylate/dicaprate, glucono-delta-lactone, PPG-1 trideceth-6

Barrier cloths: cellulose fiber/polyester (PET) fiber

Questions or Comments?

800-323-2220

Comfort Shield Barrier

INGREDIENTS AND APPEARANCE

COMFORT SHIELD BARRIER 
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-915
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-915-50	3 in 1 PACKAGE	01/01/1990
1		26 g in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 53462-915-51	3 in 1 PACKAGE	01/01/1990
2		19 g in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 53462-915-62	24 in 1 PACKAGE	01/01/1990
3		24 g in 1 APPLICATOR; Type 0: Not a Combination Product
4	NDC: 53462-915-80	8 in 1 PACKAGE	01/01/1990
4		27 g in 1 APPLICATOR; Type 0: Not a Combination Product
5	NDC: 53462-915-81	8 in 1 PACKAGE	01/01/1990
5		19 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/1990

Labeler - Sage Products LLC (054326178)