SPL v2
SPL
SPL Set ID c2c8ccca-ec9a-48c4-b4e1-4b13bb660bd0
Route
TOPICAL
Published
Effective Date 2017-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Aloe Vera Leaf Carbomer Copolymer Type A Glycerin Isopropyl Myristate Propylene Glycol .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-27

Description

Active Ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warning

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

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

Indications and Usage

Uses

To help reduce bacteria and germs on the skin.

Dosage and Administration

Directions

  • Place enough product in palm to cove rhands and rub hands briskly together until dry.
  • Children under 6, use only under adult supervision.
  • Not recommended for infants.
Description

Active Ingredient Ethyl Alcohol 62%

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

aloe barbadensis gel, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, triethanolamine, water

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)

Uses

To help reduce bacteria and germs on the skin.

Dosage and Administration (34068-7)

Directions

  • Place enough product in palm to cove rhands and rub hands briskly together until dry.
  • Children under 6, use only under adult supervision.
  • Not recommended for infants.
Warnings and Precautions (34071-1)

Warning

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

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

aloe barbadensis gel, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, triethanolamine, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)