SPL v1
SPL
SPL Set ID c105e108-c9a1-4a1d-bdbd-51101a7dd7a8
Route
TOPICAL
Published
Effective Date 2020-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (42 mL)
Inactive Ingredients
Water Trolamine Glycerin Carbomer Homopolymer, Unspecified Type Polysorbate 20 .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-01

Description

Alcohol (70%)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol (70%)

Uses

Hand sanitizer for decreasing bacteria on skin

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

When using this product Avoid contact with eyes. in case of contact, rinse eyes thoroughly with water. Avoid contact with broken, irritate. or itching skin.

Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

If pregnant or brest-feeding, ask a health professional before use.

Directions

Apply the appropriate amount of the product onto your hands and spread it thoroughly.

Rub hands together until it dries.

Active Ingredient

Alcohol (70%)

Inactive Ingredients

Water, Triethanolamine, Glycerin, Carbomer, Polysorbate 20, Tocopheryl Acetate, Perfume

Keep Out of Reach of Children

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Package Label.principal Display Panel


Structured Label Content

Uses

Hand sanitizer for decreasing bacteria on skin

Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

For external use only

Do not use if you are allergic to any of the ingredients

When using this product Avoid contact with eyes. in case of contact, rinse eyes thoroughly with water. Avoid contact with broken, irritate. or itching skin.

Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

If pregnant or brest-feeding, ask a health professional before use.

Directions

Apply the appropriate amount of the product onto your hands and spread it thoroughly.

Rub hands together until it dries.

Active Ingredient (ACTIVE INGREDIENT)

Alcohol (70%)

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Triethanolamine, Glycerin, Carbomer, Polysorbate 20, Tocopheryl Acetate, Perfume

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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