SPL v5
SPL
SPL Set ID 0e1f48d4-4cdc-7ebf-e063-6394a90a108b
Route
TOPICAL
Published
Effective Date 2024-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Propylene Glycol Water Peg-10 Dimethicone (600 Cst) Aloe Vera Leaf Peg-7 Glyceryl Cocoate Glycerin Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-29

Description

Ethyl Alcohol 70% v/v


Medication Information

Warnings and Precautions



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

Indications and Usage



Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Dosage and Administration



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

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

Description

Ethyl Alcohol 70% v/v

Section 44425-7



• Store below 110°F (43°C).

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

• May discolor certain fabrics or surfaces.

Section 50565-1



Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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 50569-3



Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50570-1



• On children less than 2 months of age.

• On open skin wounds.

Section 51727-6



Water, Peg-10 Dimethicone, Aloe Barbadensis Extract, Glycerin, Propylene Glycol, Peg-7 Glyceryl Cocoate,

Tocopheryl Acetate.

Section 51945-4

Section 55105-1



Antiseptic

Section 55106-9



Ethyl Alcohol 70% v/v


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.

Dosage and Administration (34068-7)



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

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

Warnings and Precautions (34071-1)



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

Section 44425-7 (44425-7)



• Store below 110°F (43°C).

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

• May discolor certain fabrics or surfaces.

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 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 50569-3 (50569-3)



Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50570-1 (50570-1)



• On children less than 2 months of age.

• On open skin wounds.

Section 51727-6 (51727-6)



Water, Peg-10 Dimethicone, Aloe Barbadensis Extract, Glycerin, Propylene Glycol, Peg-7 Glyceryl Cocoate,

Tocopheryl Acetate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Antiseptic

Section 55106-9 (55106-9)



Ethyl Alcohol 70% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)