Alcohol Antiseptic Hand Sanitizer Non-sterile Solution

Alcohol Antiseptic Hand Sanitizer Non-sterile Solution
SPL v1
SPL
SPL Set ID ae41da2e-8d69-b5be-e053-2a95a90a8e8c
Route
TOPICAL
Published
Effective Date 2020-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.8 mL)
Inactive Ingredients
Aloe Vera Leaf .alpha.-tocopherol Carbomer Homopolymer, Unspecified Type Tea Leaf Water Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-12

Description

Alcohol 80% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 80% v/v

Use[s]

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 continuously 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 between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

Active Ingredient[s]

Alcohol 80% v/v

Inactive Ingredients

Aloe Vera, Vitamin E, Carbomer, TEA, Deionized Water, Fragrance, fd&c blue no.1

Package Labeling: 1000

Package Labeling:50 Ml

Package Labeling:100 Ml

Package Labeling:250 Ml

Package Labeling:500 Ml

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 Chilren.

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


Structured Label Content

Use[s]

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 continuously 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 between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

Active Ingredient[s] (Active ingredient[s])

Alcohol 80% v/v

Inactive Ingredients (Inactive ingredients)

Aloe Vera, Vitamin E, Carbomer, TEA, Deionized Water, Fragrance, fd&c blue no.1

Package Labeling: 1000

Package Labeling:50 Ml (Package Labeling:50 ml)

Package Labeling:100 Ml (Package Labeling:100 ml)

Package Labeling:250 Ml (Package Labeling:250 ml)

Package Labeling:500 Ml (Package Labeling:500 ml)

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 Chilren. (Keep out of reach of chilren.)

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


Advanced Ingredient Data


Raw Label Data

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