SPL v1
SPL
SPL Set ID a5e3fd2e-5bde-110c-e053-2a95a90a59e0
Route
TOPICAL
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Maltodextrin Propylene Glycol Water Aloe Vera Leaf Glycerin Carbomer Interpolymer Type A (55000 Cps) Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-18

Description

Active Ingredient Ethyl Alcohol 75%


Medication Information

Warnings and Precautions

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Indications and Usage

Uses

Hand sanitizer to reduce bacteria on the skin.

Dosage and Administration

Directions

  • Place enough product on hand to cover fully
  • Rub hands together until dry
  • Children under 6 years of age should be supervised when using this product.
Description

Active Ingredient Ethyl Alcohol 75%

Section 44425-7

Other Information

Store below 110 F.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develops and persists.

Section 50567-7

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

water.

Section 51727-6

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin,Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate.

Section 51945-4

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active Ingredient

Ethyl Alcohol 75%


Structured Label Content

Indications and Usage (34067-9)

Uses

Hand sanitizer to reduce bacteria on the skin.

Dosage and Administration (34068-7)

Directions

  • Place enough product on hand to cover fully
  • Rub hands together until dry
  • Children under 6 years of age should be supervised when using this product.
Warnings and Precautions (34071-1)

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Section 44425-7 (44425-7)

Other Information

Store below 110 F.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develops and persists.

Section 50567-7 (50567-7)

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

water.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin,Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 75%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)