SPL v1
SPL
SPL Set ID 81b1ae2a-f2d6-40aa-a2a3-3c654792c876
Route
TOPICAL
Published
Effective Date 2020-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Aloe Water Polysorbate 20 Orange Peel Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-13

Description

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry .

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry .

Use

Hand Sanitizer to help reduce bacteria on the skin.

Section 42229-5
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. 

Section 50567-7

When using this product do not use in or near eyes. If contact occurs, 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.

Warnings

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

Directions
  • Place enough product in your palm to cover hands and rub hands together briskly 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
Other Information
  • Store below 110°F (43°C)
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

deionized water, glycerin, polysorbate 20, aloe leaf juice, orange peel oil, tocopheryl acetate, maltodextrin, parfum

Package Label Principal Display Panel


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin.

Section 42229-5 (42229-5)
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. 

Section 50567-7 (50567-7)

When using this product do not use in or near eyes. If contact occurs, 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.

Purpose

Antiseptic, Hand Sanitizer

Warnings

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

Directions
  • Place enough product in your palm to cover hands and rub hands together briskly 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
Other Information (Other information)
  • Store below 110°F (43°C)
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

deionized water, glycerin, polysorbate 20, aloe leaf juice, orange peel oil, tocopheryl acetate, maltodextrin, parfum

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)