SPL v1
SPL
SPL Set ID 8167fdaa-7116-4015-8a92-3e03ebdf4e37
Route
TOPICAL
Published
Effective Date 2020-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Aminomethylpropanol .alpha.-tocopherol Acetate Carbomer 940 Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-04

Description

Ethyl Alcohol 75% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v

Use

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

Warnings

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

Directions
  • Place 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
  • on children less than 2 months of age
  • on open skin wounds
Active Ingredient

Ethyl Alcohol 75% v/v

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

glycerin, aminomethylpropanol, alpha-tocopherol acetate, carbomer 940, aloe vera leaf, water

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.

Package Label Principal Display Panel

NDC 78710-075-02

REGAL-CARETM

# 20040

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

2 oz/ 60 mL

78710-075-04

REGAL-CARETM

# 20055

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

4 oz/ 120 mL

78710-075-08

REGAL-CARETM

# 20060

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

8 oz/ 250 mL - PUMP

78710-075-17

REGAL-CARETM

# 20070

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

16.9 oz/ 500 mL - PUMP


Structured Label Content

Use

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

Purpose

Antiseptic

Warnings

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

Directions
  • Place 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)
  • on children less than 2 months of age
  • on open skin wounds
Active Ingredient

Ethyl Alcohol 75% v/v

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

glycerin, aminomethylpropanol, alpha-tocopherol acetate, carbomer 940, aloe vera leaf, water

When Using This Product (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 (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

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

NDC 78710-075-02

REGAL-CARETM

# 20040

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

2 oz/ 60 mL

78710-075-04

REGAL-CARETM

# 20055

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

4 oz/ 120 mL

78710-075-08

REGAL-CARETM

# 20060

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

8 oz/ 250 mL - PUMP

78710-075-17

REGAL-CARETM

# 20070

Disinfection and Sterilization

HAND SANITIZER 75% ALCOHOL GEL

Contains Aloe!

Quick-Drying!

  • Rub On
  • Dries Fast
  • Non-Sticky
  • Bacteria Sterilization for Hand Protection

16.9 oz/ 500 mL - PUMP


Advanced Ingredient Data


Raw Label Data

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