81b1ae2a-f2d6-40aa-a2a3-3c654792c876

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

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 .


Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.
Other Information
  • Store below 110°F (43°C)
Inactive Ingredients

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

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.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel


Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

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.
Other Information (Other information)
  • Store below 110°F (43°C)
Inactive Ingredients (Inactive ingredients)

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

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.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)