SPL v2
SPL
SPL Set ID a7da75b3-b55d-641c-e053-2995a90a43b7
Route
TOPICAL
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (68 mL)
Inactive Ingredients
Glycerin Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-01

Description

Alcohol 68% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 68% v/v. Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and 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 occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. If contact occurs with eyes, rinse thoroughly with water.



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



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

Warnings

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

Directions
  • Spray enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Product Identity

Hand Sanitizer - Antibacterial Spray

3.4 fl oz | 100 ml

6.8 fl oz | 200 ml

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 68% v/v. Purpose: Antiseptic

Inactive Ingredients

purified water, aloe barbadensis leaf juice powder, glycerin.

Hand Sanitizer Spray Package Label

100 mL NDC: 70983-025-01

200 mL NDC: 70983-025-02


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and 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 occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. If contact occurs with eyes, rinse thoroughly with water.



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



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

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions
  • Spray enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Product Identity

Hand Sanitizer - Antibacterial Spray

3.4 fl oz | 100 ml

6.8 fl oz | 200 ml

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 68% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

purified water, aloe barbadensis leaf juice powder, glycerin.

Hand Sanitizer Spray Package Label (Hand Sanitizer Spray - Package Label)

100 mL NDC: 70983-025-01

200 mL NDC: 70983-025-02


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)