SPL v1
SPL
SPL Set ID 4778d80a-a4b2-46c4-8dbe-783fc40b6ea3
Route
TOPICAL
Published
Effective Date 2020-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Glycerin Water Carbomer 934 Triethanolamine Sulfate Aloe Vera Whole Propylene Glycol .alpha.-tocopherol Acetate

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

When water, soap, and towel are not available

Recommended for repeaded use

Section 42229-5

NA

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9

Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours

Section 50567-7

Do not apply around eyes

Do not use in ears and mouth

When using this product avoid contact with eyes. In case of contact, flush eyes with water.

Section 51945-4

Warnings

For external use only.

Flammable. Keep away from fire or flame

Directions

Wet hands thoroughly with products and rub into skin until dry

Other Information

Store at 20C (68-77F)

May discolor fabrics

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Inactive Ingredients

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


Structured Label Content

Use

Hand sanitizer to help reduce bacteria on the skin

When water, soap, and towel are not available

Recommended for repeaded use

Section 42229-5 (42229-5)

NA

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours

Section 50567-7 (50567-7)

Do not apply around eyes

Do not use in ears and mouth

When using this product avoid contact with eyes. In case of contact, flush eyes with water.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from fire or flame

Directions

Wet hands thoroughly with products and rub into skin until dry

Other Information (Other information)

Store at 20C (68-77F)

May discolor fabrics

Active Ingredient(s)

Ethyl Alcohol 62% v/v

Inactive Ingredients (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)