SPL v3
SPL
SPL Set ID 53f7154a-2ed8-4f08-b72a-3eddf033ea2c
Route
TOPICAL
Published
Effective Date 2020-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Water Carbomer 934 Alpha-tocopherol Acetate Trolamine Aloe Vera Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-22 Until 2020-05-23

Description

NA

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

NA

Use

For hand washing to decrease bacteria on the skin

Recommended for repeated use

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 and redness develop and persist for more than 72 hours

Section 50567-7

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

Section 51945-4

Warnings

For external use only

Flammable. Keep away from heat and flame

Directions

Wet hands thoroughly with product.

Rub hands together briskly untill dry

Supervise children under 6 years in the use of this product

Other Information

Store at 20-25C (68-77F)

May discolor certain fabrics

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

Water, glycerin, carbomer, aloe vera, triethanolamine, tocopheryl acetate


Structured Label Content

Use

For hand washing to decrease bacteria on the skin

Recommended for repeated use

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 and redness develop and persist for more than 72 hours

Section 50567-7 (50567-7)

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

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For external use only

Flammable. Keep away from heat and flame

Directions

Wet hands thoroughly with product.

Rub hands together briskly untill dry

Supervise children under 6 years in the use of this product

Other Information (Other information)

Store at 20-25C (68-77F)

May discolor certain fabrics

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Water, glycerin, carbomer, aloe vera, triethanolamine, tocopheryl acetate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)