SPL v1
SPL
SPL Set ID 3d848ec8-5197-6d39-e063-6394a90aaef6
Route
TOPICAL
Published
Effective Date 2025-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (72 mL)
Inactive Ingredients
Peg-10 Dimethicone (200 Cst) Glycerin Isopropyl Myristate Water Edetate Disodium Aloe Barbadensis Leaf Juice .alpha.-tocopherol Acetate Polyquaternium-11 (1000000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

Ethyl Alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v

Uses

Uses hand sanitizer to help reduce bacteria on the skin that could cause disease

Section 51945-4

Warnings

Warnings

For external use only

FLAMMABLE. Keep away from fire or flame

Directions

Directions

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

Ethyl Alcohol 70% v/v

Inactive Ingredients

Inactive Ingredients Aloe Barbadensis Leaf Juice, Disodium EDTA, Glycerin, Isopropyl Myristate, PEG-10 Dimethicone, Polyquaternium-11, Tocopheryl Acetate, Water

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
  • avoid contact with broken skin
  • do not inhale or ingest
Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persists for more than 72 hours
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


Structured Label Content

Uses

Uses hand sanitizer to help reduce bacteria on the skin that could cause disease

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

Warnings

For external use only

FLAMMABLE. Keep away from fire or flame

Directions

Directions

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

Ethyl Alcohol 70% v/v

Inactive Ingredients

Inactive Ingredients Aloe Barbadensis Leaf Juice, Disodium EDTA, Glycerin, Isopropyl Myristate, PEG-10 Dimethicone, Polyquaternium-11, Tocopheryl Acetate, Water

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
  • avoid contact with broken skin
  • do not inhale or ingest
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persists for more than 72 hours
Keep Out of Reach of Children. (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

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