SPL v1
SPL
SPL Set ID a6c0b772-8af5-64ce-e053-2995a90a34ab
Route
TOPICAL
Published
Effective Date 2020-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Maltodextrin Propylene Glycol Water Aloe Vera Leaf Glycerin Carbomer Interpolymer Type A (55000 Cps) Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-29

Description

Active Ingredient Ethyl Alcohol 62% v/v


Medication Information

Warnings and Precautions

Warnings:

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

Indications and Usage

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water not available.

Dosage and Administration

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.

Description

Active Ingredient Ethyl Alcohol 62% v/v

Section 44425-7

Other Information:

Store between 15-30℃(59-86℉)

Avoid freezing and excessive heat above 40℃(104℉)

May discolor certain fabrics or surfaces.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right way.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1

Do not use:

On children less than 2 months of age

On open skin wounds

Section 51727-6

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin,Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate Crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate.

Section 51945-4

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 62% v/v


Structured Label Content

Indications and Usage (34067-9)

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water not available.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings:

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

Section 44425-7 (44425-7)

Other Information:

Store between 15-30℃(59-86℉)

Avoid freezing and excessive heat above 40℃(104℉)

May discolor certain fabrics or surfaces.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right way.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Do not use:

On children less than 2 months of age

On open skin wounds

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin,Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate Crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 62% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)