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

Purpose

Antiseptic

Description

Isopropyl alcohol 75% v/v


Medication Information

Warnings

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

Purpose

Antiseptic

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.

Other Information

• Store between 15-30C (59-86F)

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

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

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.

Do Not Use

• in children less than 2 months of age

• on open skin wounds

Drug Facts

Package Labeling:

Active Ingredient[s]

Isopropyl alcohol 75% v/v

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

Warnings

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

Purpose

Antiseptic

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.

Other Information (Other information)

• Store between 15-30C (59-86F)

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

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, purified water USP

Use[s]

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

Do Not Use (Do not use)

• in children less than 2 months of age

• on open skin wounds

Drug Facts

Package Labeling:

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

Isopropyl alcohol 75% v/v

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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