SPL v4
SPL
SPL Set ID 3a7a7429-ba4e-46c6-a655-212fe8e52bba
Route
TOPICAL
Published
Effective Date 2020-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

Ethyl Acohol, 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Acohol, 70% v/v

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Recommended for repeated use.

Section 50565-1

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

Warnings

Flammable. Keep away from heat or flame.

For external use only.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Other information

  • Store below 110 0F (43 0C)
  • May discolor certain fabrics or surfaces
Active Ingredient

Ethyl Acohol, 70% v/v

Inactive Ingredients

Aloe Vera Extract, Carbomero, Glycerin, Fragance (Parfum), Purified Water (Aqua), Triethanolamine

Package Label Principal Display Panel

45 mL Label

60 mL Label

120 mL Label

240 mL Label

500 mL label


Structured Label Content

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Recommended for repeated use.

Section 50565-1 (50565-1)

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

Purpose

Antiseptic

Warnings

Flammable. Keep away from heat or flame.

For external use only.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Other information

  • Store below 110 0F (43 0C)
  • May discolor certain fabrics or surfaces
Active Ingredient

Ethyl Acohol, 70% v/v

Inactive Ingredients (Inactive ingredients)

Aloe Vera Extract, Carbomero, Glycerin, Fragance (Parfum), Purified Water (Aqua), Triethanolamine

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

45 mL Label

60 mL Label

120 mL Label

240 mL Label

500 mL label


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)