SPL v2
SPL
SPL Set ID fd8f14d8-8292-491b-9c66-1bd9767e5fda
Route
TOPICAL
Published
Effective Date 2020-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Glycerol Formal Carbomer 934 Trolamine Tocopherol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-10

Description

NA

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

NA

Use

Hand sanitizer to help decrease bacterial on the skin

When water, soap and towel are not available

Recommended for repeated use

Section 42229-5

NA

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

Section 50567-7

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. 

Do not apply around eyes. 

Do not use in ears and mouth.

Directions

Pump as needed into your palms and thoroughly spread on both hands

Rub into skin until dry.

Other Information

Store at 20C (68 to 77F)

May discolor fabrics

Active Ingredient(s)

Ethyl Alcohol 62%

Inactive Ingredients

Water, carbomer, triethanolamine, glycerol, aloe barbadensis leaf juice


Structured Label Content

Use

Hand sanitizer to help decrease bacterial on the skin

When water, soap and towel are not available

Recommended for repeated 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 products.

Section 50566-9 (50566-9)

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

Section 50567-7 (50567-7)

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. 

Do not apply around eyes. 

Do not use in ears and mouth.

Directions

Pump as needed into your palms and thoroughly spread on both hands

Rub into skin until dry.

Other Information (Other information)

Store at 20C (68 to 77F)

May discolor fabrics

Active Ingredient(s)

Ethyl Alcohol 62%

Inactive Ingredients (Inactive ingredients)

Water, carbomer, triethanolamine, glycerol, aloe barbadensis leaf juice


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)