SPL v2
SPL
SPL Set ID a442b3bb-0fad-2b9a-e053-2995a90ac65d
Route
TOPICAL
Published
Effective Date 2020-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Trolamine Levomenthol Green Tea Leaf Aloe Vera Leaf Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-30

Description

Alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v

Use
  • Hand sanitizer to help reduce bacteria that potentially can cause disease.
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 occurs. These may be signs of serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. 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 thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Supervise children when using this product to avoid swallowing.
Qusetions?

1.310.635.7007

Active Ingredient

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, Glycerin, Carbomer, Trolamine, L-Menthol, Green Tea Leaf, Aloe Vera Leaf

Package Label Principal Display Panel


Structured Label Content

Use
  • Hand sanitizer to help reduce bacteria that potentially can cause disease.
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 occurs. These may be signs of serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. 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 thoroughly cover your hands.
  • Rub hands together briskly until dry.
  • Supervise children when using this product to avoid swallowing.
Qusetions?

1.310.635.7007

Active Ingredient

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, Glycerin, Carbomer, Trolamine, L-Menthol, Green Tea Leaf, Aloe Vera Leaf

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)