SPL v3
SPL
SPL Set ID 01c826ab-464c-98e2-e063-6394a90aba20
Route
TOPICAL
Published
Effective Date 2023-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Lemon Oil Glycerin Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Triethanolamine Dodecylbenzenesulfonate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-08-06

Description

Alcohol 70% v/v


Medication Information

Indications and Usage

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Description

Alcohol 70% v/v

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 rash occurs. These may be signs of a serious condition.

Section 50567-7

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

Section 51945-4

Section 55105-1



Antiseptic

Section 55106-9



Alcohol 70% v/v

Warnings

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

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using products.

Do Not Use

• On children less than 2 months of age. • On open skin wounds.

Other Information

• Store below 110°F (43°C).

• Avoid freezing and excessive heat above 104°F (40°C).

• May discolor certain fabrics or surfaces.

Inactive Ingredients

Aloe Vera, Carbomer Interpolymer (type B),Lemon oil,Glycerin,Triethanolamine, Water (Aqua).


Structured Label Content

Indications and Usage (34067-9)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Antiseptic

Section 55106-9 (55106-9)



Alcohol 70% v/v

Warnings

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

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using products.

Do Not Use (Do not use)

• On children less than 2 months of age. • On open skin wounds.

Other Information (Other information)

• Store below 110°F (43°C).

• Avoid freezing and excessive heat above 104°F (40°C).

• May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Aloe Vera, Carbomer Interpolymer (type B),Lemon oil,Glycerin,Triethanolamine, Water (Aqua).


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)