060 Aloetouch Protect

060 Aloetouch Protect
SPL v7
SPL
SPL Set ID 43a3f0f7-f76f-434d-a21f-7eaa3638913d
Route
TOPICAL
Published
Effective Date 2023-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (0.544 g)
Inactive Ingredients
Water Polysorbate 20 Sodium Benzoate Benzalkonium Chloride Aloe Vera Leaf Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2007-01-01 Until 2027-06-30

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
  • protects minor skin irritation associated with perineal dermatitis

Warnings

For external use only

Directions
  • Open package as designated
  • Remove cloths and thoroughly cleanse soiled area
  • Apply as needed
  • Dispose of cloth in waste receptacle
Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns

Package Label

Active Ingredient

Dimethicone 3.2%

Other Information
  • Protect from freezing, avoid excessive heat
  • Keep lid tightly sealed
  • Not made with Natural Rubber Latex
  • Do not flush
  • Cloth: made of Rayon/Polyester
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Disodium EDTA, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Simethicone, Sodium Benzoate, Polysorbate 20, Water (Aqua)

When Using This Product
  • avoid direct contact with eyes
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children.

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


Structured Label Content

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

Purpose

Skin Protectant

Warnings

For external use only

Directions
  • Open package as designated
  • Remove cloths and thoroughly cleanse soiled area
  • Apply as needed
  • Dispose of cloth in waste receptacle
Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns

Package Label

Active Ingredient (Active ingredient)

Dimethicone 3.2%

Other Information (Other information)
  • Protect from freezing, avoid excessive heat
  • Keep lid tightly sealed
  • Not made with Natural Rubber Latex
  • Do not flush
  • Cloth: made of Rayon/Polyester
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Disodium EDTA, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Simethicone, Sodium Benzoate, Polysorbate 20, Water (Aqua)

When Using This Product (When using this product)
  • avoid direct contact with eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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