SPL v1
SPL
SPL Set ID a2f30f9a-ffb3-e8ed-e053-2995a90af3b0
Route
TOPICAL
Published
Effective Date 2020-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (1.8 mL)
Inactive Ingredients
Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Hand Sanitizer Spray

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Hand Sanitizer Spray

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5

Hand Sanitizer Spray

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, and mouth. In case of contact with eyes, rinse eyes 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, get medical help or contact a Poison Control Center right away.

Section 51945-4

120mL NDC:74983-120-02

120 mL NDC:74983-120-02

Warnings

Flammable. Keep away from fire or flame. For External use only. When using this product do not use in mouth, ears, open skin wounds, or eyes. In case of contact, rinse eye thoroughly with water.

Directions
  • Spray directly on hands and rub in throughly.
  • Children under 6 years old should be supervised when using this product. Do not us on children less than 2 months of age.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
  • Ears
  • mouth
  • eyes
Other Information
  • Store below 104F (40C). May discolor certain fabrics or surfaces.
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, purified water USP


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 42229-5 (42229-5)

Hand Sanitizer Spray

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, and mouth. In case of contact with eyes, rinse eyes 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, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

120mL NDC:74983-120-02

120 mL NDC:74983-120-02

Purpose

Antiseptic, Hand Sanitizer

Warnings

Flammable. Keep away from fire or flame. For External use only. When using this product do not use in mouth, ears, open skin wounds, or eyes. In case of contact, rinse eye thoroughly with water.

Directions
  • Spray directly on hands and rub in throughly.
  • Children under 6 years old should be supervised when using this product. Do not us on children less than 2 months of age.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
  • Ears
  • mouth
  • eyes
Other Information (Other information)
  • Store below 104F (40C). May discolor certain fabrics or surfaces.
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycerin, purified water USP


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)