Personal Cleansing Cloth With Dimethicone

Personal Cleansing Cloth With Dimethicone
SPL v5
SPL
SPL Set ID 3f9a1a90-ab12-4911-b8c2-df200b0dde5b
Route
TOPICAL
Published
Effective Date 2019-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (32 mg)
Inactive Ingredients
Water Glycerin Ppg-15 Stearyl Ether Glyceryl Monostearate Peg-100 Stearate Phenoxyethanol Aloe Vera Leaf Caprylyl Glycol Cetostearyl Alcohol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-15

Description

Dimethicone 3.2%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone 3.2%

Uses
  • temporarily protects and helps relieve chapped or cracked skin
  • helps prevent perineal dermatitis 
  • protects minor skin irritation associated with perineal dermatitis
Warnings

For external use only

Directions
  • Pull back label and remove wipes
  • Thoroughly cleanse soiled area, using one wipe at a time
  • Use as often as necessary
  • Dispose of cloths in a waste receptacle
  • Do not flush 
  • Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed:
  • In a single warming session at temperatures not exceeding 52°C (125°F) and 
  • for a maximum of 200 hours. Discard wipes that have been:
  • Exposed to warming temperatures exceeding 52°C (125°F); or 
  • Stored longer than 200 hours within the warmer; or
  • Been warmed, allowed to cool, and then re-warmed

Warming Instructions:

Do Not Use
  • On deep or puncture wounds
  • Animal bites
  • Serious burns
Active Ingredient

Dimethicone 3.2%

Other Information

When not in a warmer, store between 15-30˚C (59-86˚F).

Package Labeling:

Inactive Ingredients

Aqua, Glycerin, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Cetearyl Alcohol, Xanthan Gum

When Using This Product
  • Avoid direct contact with the eyes
Keep Out of Reach of Children.

If swallowed, get medical help or contact Posion Control Center right away.

  • Discontinue if irritation or redness develops
  • Gloves diminish sensitivity to heat
  • Closely monitor heat level with infants, unresponsive or skin sensitive individuals
Stop Use and Contact A Physician
  • if condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Structured Label Content

Uses
  • temporarily protects and helps relieve chapped or cracked skin
  • helps prevent perineal dermatitis 
  • protects minor skin irritation associated with perineal dermatitis
Purpose

Skin Protectant

Warnings

For external use only

Directions
  • Pull back label and remove wipes
  • Thoroughly cleanse soiled area, using one wipe at a time
  • Use as often as necessary
  • Dispose of cloths in a waste receptacle
  • Do not flush 
  • Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed:
  • In a single warming session at temperatures not exceeding 52°C (125°F) and 
  • for a maximum of 200 hours. Discard wipes that have been:
  • Exposed to warming temperatures exceeding 52°C (125°F); or 
  • Stored longer than 200 hours within the warmer; or
  • Been warmed, allowed to cool, and then re-warmed

Warming Instructions:

Do Not Use (Do not use)
  • On deep or puncture wounds
  • Animal bites
  • Serious burns
Active Ingredient

Dimethicone 3.2%

Other Information

When not in a warmer, store between 15-30˚C (59-86˚F).

Package Labeling:

Inactive Ingredients

Aqua, Glycerin, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Cetearyl Alcohol, Xanthan Gum

When Using This Product (When using this product)
  • Avoid direct contact with the eyes
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact Posion Control Center right away.

  • Discontinue if irritation or redness develops
  • Gloves diminish sensitivity to heat
  • Closely monitor heat level with infants, unresponsive or skin sensitive individuals
Stop Use and Contact A Physician (Stop use and contact a physician)
  • if condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Advanced Ingredient Data


Raw Label Data

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