SPL v1
SPL
SPL Set ID 51a8424b-b0cd-446f-9f30-b3f3e432be9d
Route
TOPICAL
Published
Effective Date 2020-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Water Carbomer 934 Propylene Glycol Alpha-tocopherol Acetate Triethanolamine Sulfate Aloe Vera Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-23

Description

NA

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

NA

Use

Hand sanitizer to help reduce bacteria on the skin

Section 42229-5

NA

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or redness develops

Section 50567-7

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Section 51945-4

Warnings

Flammable. Keep away from fire or flame

For external use only.

Directions

Appply to palm of hands. Rub hands together vigorously untill dry.

Supervise chirldren in the use of this product.

Other Information

Do not store above 110F (43C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients

Water, triethanolamine, carbomer, aloe barbadensis (Aloe vera) gel, fragrance, propylene glycol, glycerin, tocopheryl acetate (Vitamin E)


Structured Label Content

Use

Hand sanitizer to help reduce bacteria on the skin

Section 42229-5 (42229-5)

NA

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

Flammable. Keep away from fire or flame

For external use only.

Directions

Appply to palm of hands. Rub hands together vigorously untill dry.

Supervise chirldren in the use of this product.

Other Information (Other information)

Do not store above 110F (43C)

May discolor certain fabrics or surfaces

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Water, triethanolamine, carbomer, aloe barbadensis (Aloe vera) gel, fragrance, propylene glycol, glycerin, tocopheryl acetate (Vitamin E)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)