SPL v1
SPL
SPL Set ID b3cbe54a-0c77-0b6c-e053-2a95a90aca27
Route
TOPICAL
Published
Effective Date 2020-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Glycerin Water Trolamine Benzalkonium Chloride

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-16

Description

Alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v

Use(s)
  • Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease. For use when soap water are not available.
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: Keep out of eyes, ears,a nd mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1

Do Not Use

*On children less then 2 months of age

*On open skin wounds

Warnings

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

Directions

*Put enough product in your palm to cover hands and rub hands together until dry.

*Children under 6 years of age should be supervised when using this product.

Other Information

*Store below 110°F (43°C)

*May discolor certain fabric

Active Ingredient(s)

Alcohol 70% v/v

Inactive Ingredients

Deionized water, glycerin carbomer, triethanolamine, benzalkonium chloride

Package Label Principal Display Panel


Structured Label Content

Use(s)
  • Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease. For use when soap water are not available.
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: Keep out of eyes, ears,a nd mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Do Not Use

*On children less then 2 months of age

*On open skin wounds

Purpose

Antiseptic

Warnings

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

Directions

*Put enough product in your palm to cover hands and rub hands together until dry.

*Children under 6 years of age should be supervised when using this product.

Other Information (Other information)

*Store below 110°F (43°C)

*May discolor certain fabric

Active Ingredient(s)

Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Deionized water, glycerin carbomer, triethanolamine, benzalkonium chloride

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)