Clean Antiseptic Wipes Non Sterile Solution Hand Sanitizer

Clean Antiseptic Wipes Non Sterile Solution Hand Sanitizer
SPL v1
SPL
SPL Set ID b79b5f68-2764-04bf-e053-2995a90a04ae
Route
TOPICAL
Published
Effective Date 2020-12-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.75 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-28

Description

Isopropyl alcohol 75% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Isopropyl alcohol 75% 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 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

Drug Facts

Other Information

• Store between 15-30C (59-86F)

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

Package Labeling:

Active Ingredient[s]

Isopropyl alcohol 75% v/v

Inactive Ingredients

glycerin, hydrogen peroxide, 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 at 1-800-222-1222.


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 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

Drug Facts

Other Information (Other information)

• Store between 15-30C (59-86F)

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

Package Labeling:

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

Isopropyl alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, 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 at 1-800-222-1222.


Advanced Ingredient Data


Raw Label Data

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