SPL v1
SPL
SPL Set ID b1897cfc-24af-1c44-e053-2a95a90a427d
Route
TOPICAL
Published
Effective Date 2020-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
.alpha.-tocopherol Acetate Water Glycerin Carbomer Homopolymer, Unspecified Type Trolamine Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-13

Description

Ethyl Alcohol 75%v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%v/v

Use
  • For hand sanitizing to decrease bacteria on the skin.
  • Recommended for repeated use.
Label

Warnings

For external use only.

Flammable, keep away from heat and flame.

Directions
  • Place enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.
Do Not Use

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Do not use on children less than 2 months of age.

Active Ingredient

Ethyl Alcohol 75%v/v

Other Information
  • Store below 110F(43C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients

Aqua(Water), Glycerin, Carbomer, Triethanolamine,Aloe,Tocopheryl Acetate(Vitamin E)

Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • Irritation or redness develop and persist for more than 72 hours.
  • Swallowed, get medical help or contact a posion control center right away.
Keep Out of Reach of Children

Children must be supervised when using of this product.


Structured Label Content

Use
  • For hand sanitizing to decrease bacteria on the skin.
  • Recommended for repeated use.
Label

Purpose

Antiseptic

Warnings

For external use only.

Flammable, keep away from heat and flame.

Directions
  • Place enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.
Do Not Use (Do not use)

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Do not use on children less than 2 months of age.

Active Ingredient (Active ingredient)

Ethyl Alcohol 75%v/v

Other Information (Other information)
  • Store below 110F(43C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

Aqua(Water), Glycerin, Carbomer, Triethanolamine,Aloe,Tocopheryl Acetate(Vitamin E)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • Irritation or redness develop and persist for more than 72 hours.
  • Swallowed, get medical help or contact a posion control center right away.
Keep Out of Reach of Children (Keep out of reach of children)

Children must be supervised when using of this product.


Advanced Ingredient Data


Raw Label Data

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