Hand Sanitizer

Hand Sanitizer
SPL v4
SPL
SPL Set ID a44bd299-eb10-4e69-e053-2995a90a5ce6
Route
TOPICAL
Published
Effective Date 2020-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.7 mL)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Glycerin Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-24

Description

Isopropyl alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Isopropyl alcohol 70% v/v

Uses

Health care personnel hand rub to help reduce bacteria that potentially can cause disease. 

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
  • in children less than 2 months of age
  • on open skin wounds
76692 000 86

76692 000 87

76692 000 88

76692 000 89

Active Ingredient

Isopropyl alcohol 70% v/v

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

Carbomer, Glycerin, Triethanolamine, Purified Water USP

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 Labeling: 76692 000 85


Structured Label Content

Uses

Health care personnel hand rub to help reduce bacteria that potentially can cause disease. 

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)
  • in children less than 2 months of age
  • on open skin wounds
76692 000 86 (76692-000-86)

76692 000 87 (76692-000-87)

76692 000 88 (76692-000-88)

76692 000 89 (76692-000-89)

Active Ingredient (Active ingredient)

Isopropyl alcohol 70% v/v

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

Carbomer, Glycerin, Triethanolamine, Purified Water USP

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 Labeling: 76692 000 85 (Package Labeling: 76692-000-85)


Advanced Ingredient Data


Raw Label Data

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