Health & Beyond

Health & Beyond
SPL v1
SPL
SPL Set ID bf207e01-68c7-3cff-e053-2a95a90a98ad
Route
TOPICAL
Published
Effective Date 2021-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Maltodextrin .alpha.-tocopherol Acetate Water Denatonium Benzoate Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Aminomethylpropanol Glycerin Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-04-05

Description

Alcohol 62% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 62% v/v

Uses
  • Hand sanitizer to help reduce bacteria that potentially can cause disease.
  • For use when soap and water are not available.
Section 51945-4

Warnings

For external use only. Flammable. Keep away from heat or flame.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 62% v/v

Other Information
  • Store between 15-30℃ (59-86F°)
  • Avoid freezing and excessive heat above 40℃(104°F)
Inactive Ingredients

Acrylates/C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Denatonium Benzoate, Fragrance(Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water(Aqua).

When Using This Product
  • keep out of eyes, ears, and mouth.
  • In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use and Ask A Doctor If

irritation or rash occurs. These may be signs of a serious condition.

Keep Out of Reach of Children

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


Structured Label Content

Uses
  • Hand sanitizer to help reduce bacteria that potentially can cause disease.
  • For use when soap and water are not available.
Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 62% v/v

Other Information
  • Store between 15-30℃ (59-86F°)
  • Avoid freezing and excessive heat above 40℃(104°F)
Inactive Ingredients

Acrylates/C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Denatonium Benzoate, Fragrance(Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water(Aqua).

When Using This Product (When using this product)
  • keep out of eyes, ears, and mouth.
  • In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation or rash occurs. These may be signs of a serious condition.

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)