SPL v1
SPL
SPL Set ID a9d68d2b-30fd-0a84-e053-2995a90a7d1c
Route
TOPICAL
Published
Effective Date 2020-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Hyaluronate Sodium 1,2-hexanediol Glycerin Butylene Glycol Water Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-07

Description

Ethyl Alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v

Use

Hand Sanitizer to help reduce bacteria on the skin.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Warnings

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

Directions
  • Place enough product on your palm to cover all surfaces and rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Active Ingredient

Ethyl Alcohol 70% v/v

Other Information
  • Avoid freezing and excessive heat above 104°F(40°C)
  • May discolor certain fabrics or surface
Inactive Ingredients

Water, Butylene Glycol, Glycerin, Aloe Vera Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Package Label Principal Display Panel


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Purpose

Antiseptic

Warnings

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

Directions
  • Place enough product on your palm to cover all surfaces and rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Active Ingredient

Ethyl Alcohol 70% v/v

Other Information (Other information)
  • Avoid freezing and excessive heat above 104°F(40°C)
  • May discolor certain fabrics or surface
Inactive Ingredients (Inactive ingredients)

Water, Butylene Glycol, Glycerin, Aloe Vera Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)