SPL v2
SPL
SPL Set ID acbde281-24dd-caa6-e053-2a95a90a6699
Route
TOPICAL
Published
Effective Date 2020-08-13
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 Interpolymer Type A (allyl Sucrose Crosslinked) Edetol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-13 Until 2022-03-08

Description

Ethyl Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

Hand Sanitizer to help reduce bacteria on the skin.

Label

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient

Ethyl Alcohol 75%

Other Information

Store below 104F(40C)

Inactive Ingredients

AQUA ,

GLYCERIN ,

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,

TETRAHYDROXYPROPYL ETHYLENEDIAMINE,

ALOE BARBADENSIS LEAF EXTRACT ,

TOCOPHERYL ACETATE

When Using This Product

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep Out of Reach of Children

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


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin.

Label

Purpose

Antiseptic

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient (Active ingredient)

Ethyl Alcohol 75%

Other Information (Other information)

Store below 104F(40C)

Inactive Ingredients (Inactive ingredients)

AQUA ,

GLYCERIN ,

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,

TETRAHYDROXYPROPYL ETHYLENEDIAMINE,

ALOE BARBADENSIS LEAF EXTRACT ,

TOCOPHERYL ACETATE

When Using This Product (When using this product)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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

Stop use and ask a doctor if irritation or rash appears and lasts.

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

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


Advanced Ingredient Data


Raw Label Data

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