Skin Protectant Flushable Wipes

Skin Protectant Flushable Wipes
SPL v5
SPL
SPL Set ID dee5ac9d-d437-4ba0-9f68-c60d8a7f49e9
Route
TOPICAL
Published
Effective Date 2016-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (3.2 g)
Inactive Ingredients
Water Linoleamidopropyl Pg-dimonium Chloride Phosphate Polysorbate 20 Edetate Disodium Cetearyl Isononanoate Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glyceryl Monostearate Ceteareth-12 Cetyl Palmitate Glycerin Sodium Benzoate Benzalkonium Chloride Phenoxyethanol Aloe Vera Leaf Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-08-03

Description

Dimethicone 3.2%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone 3.2%

Use

Temporarily protects and helps relieve chapped or cracked skin

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Warnings

For external use only

When using this product do not get into eyes.

Stop use and ask a doctor if

  • condition worsens

  • symptoms last more than 7 days to clear up and occur again within a few days
  • irritation or redness develops

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns


Directions
  • Open package as designated
  • Remove cloth and apply to the soiled area
  • Apply as needed
  • Dispose of cloth in waste receptacle or flush in toilet

Active Ingredient

Dimethicone 3.2%

Other Information

Store at room temperature

Inactive Ingredients

WATER, SODIUM COCO PG-DIMONIUM CHLORIDE PHOSPHATE, LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, POLYSORBATE-20, DISODIUM EDTA, CETEARYL ISONONANOATE, CETEARETH-20, CETEARYL ALCOHOL, GLYCERYL STEARATE, CETEARETH-12, CETYL PALMITATE, GLYCERIN, SODIUM BENZOATE, BENZALKONIUM CHLORIDE, PHENOXYETHANOL, ALOE VERA LEAF JUICE, CITRIC ACID

Skin Protectant Flushable Wipes



Skin Protectant Flushable Wipes 24 Wipes (44019 004 00)


Structured Label Content

Use

Temporarily protects and helps relieve chapped or cracked skin

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Purpose

Skin Protectant

Warnings

For external use only

When using this product do not get into eyes.

Stop use and ask a doctor if

  • condition worsens

  • symptoms last more than 7 days to clear up and occur again within a few days
  • irritation or redness develops

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns


Directions
  • Open package as designated
  • Remove cloth and apply to the soiled area
  • Apply as needed
  • Dispose of cloth in waste receptacle or flush in toilet

Active Ingredient

Dimethicone 3.2%

Other Information

Store at room temperature

Inactive Ingredients

WATER, SODIUM COCO PG-DIMONIUM CHLORIDE PHOSPHATE, LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, POLYSORBATE-20, DISODIUM EDTA, CETEARYL ISONONANOATE, CETEARETH-20, CETEARYL ALCOHOL, GLYCERYL STEARATE, CETEARETH-12, CETYL PALMITATE, GLYCERIN, SODIUM BENZOATE, BENZALKONIUM CHLORIDE, PHENOXYETHANOL, ALOE VERA LEAF JUICE, CITRIC ACID

Skin Protectant Flushable Wipes



Skin Protectant Flushable Wipes 24 Wipes (44019 004 00) (Skin Protectant Flushable Wipes 24 Wipes (44019-004-00))


Advanced Ingredient Data


Raw Label Data

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