Comfort Shield Barrier Cream Cloths

Comfort Shield Barrier Cream Cloths
SPL v16
SPL
SPL Set ID cc08f571-84ae-4c2f-b09d-a83a8efc39f5
Route
TOPICAL
Published
Effective Date 2016-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (30 mg)
Inactive Ingredients
Water Glyceryl Monostearate Peg-100 Stearate Isopropyl Palmitate Cetyl Alcohol Glycerin Stearyl Alcohol Phenoxyethanol Methylpropanediol Chlorhexidine Gluconate Hydroxyethyl Cellulose (4000 Mpa.s At 1%) Ethylhexylglycerin Polyquaternium-37 (25000 Mpa.s) Propylene Glycol Dicaprylate/dicaprate Gluconolactone Ppg-1 Trideceth-6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1990-01-01 Until 2025-10-07

Description

Dimethicone 3%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 3%

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

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

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

Warnings

For external perineal use only. 

Avoid contact with the eyes.

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
Active Ingredient

Dimethicone 3%

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

Comfort Shield Barrier

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
Questions Or Comments?

800-323-2220


Structured Label Content

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

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

Purpose

Skin protectant

Warnings

For external perineal use only. 

Avoid contact with the eyes.

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
Active Ingredient

Dimethicone 3%

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

Comfort Shield Barrier

If Warming Is Desired: (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
Questions Or Comments? (Questions or Comments?)

800-323-2220


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)