SPL v1
SPL
SPL Set ID 82d1f12a-975e-7c19-e053-2991aa0a20a1
Route
TOPICAL
Published
Effective Date 2019-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Polysorbate 20 Ext. D&c Violet No. 2 Carbomer Homopolymer Type C Edetol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-02-01

Description

Ethyl Alcohol 70% v/v


Medication Information

Warnings and Precautions

Flammable. Keep away from source of heat, fire or flame.

For external use only.

When using this product avoid contact with eyes. If contact

occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develops and

lasts.

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center immediately.

Dosage and Administration

• place enough product in your palm to thoroughly cover your

hands and rub hands together until dry.

• children under 6 years should be supervised when using this

product.

Description

Ethyl Alcohol 70% v/v

Uses

Hand Sanitizer to help reduce bacteria on the skin

Section 55106-9

Ethyl Alcohol 70% v/v

Directions

• place enough product in your palm to thoroughly cover your

hands and rub hands together until dry.

• children under 6 years should be supervised when using this

product.

Packaging Label

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Ext. Violet 2 (CI 60730), Fragrance (Parfum), Polysorbate 20, Tetrahydroxypropyl Ethylenediamine, Water (Aqua).

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Uses

Hand Sanitizer to help reduce bacteria on the skin

Dosage and Administration (34068-7)

• place enough product in your palm to thoroughly cover your

hands and rub hands together until dry.

• children under 6 years should be supervised when using this

product.

Warnings and Precautions (34071-1)

Flammable. Keep away from source of heat, fire or flame.

For external use only.

When using this product avoid contact with eyes. If contact

occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develops and

lasts.

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center immediately.

Section 55106-9 (55106-9)

Ethyl Alcohol 70% v/v

Directions

• place enough product in your palm to thoroughly cover your

hands and rub hands together until dry.

• children under 6 years should be supervised when using this

product.

Packaging Label (packaging label)

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Ext. Violet 2 (CI 60730), Fragrance (Parfum), Polysorbate 20, Tetrahydroxypropyl Ethylenediamine, Water (Aqua).

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)