f7968dca-0e04-4d70-af41-63008e1fc8c1

SPL v1
SPL
SPL Set ID f7968dca-0e04-4d70-af41-63008e1fc8c1
Route
topical
Published
Effective Date 2020-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (42 mL)
Inactive Ingredients
water carbomer homopolymer, unspecified type glycerin propylene glycol trolamine polysorbate 80 aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-01

Purpose

ANTISEPTIC

Description

Ethyl alcohol 70%


Medication Information

Warnings

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

--------------------------------------------------------------------------------------------------------

Do not use

• in children less than 2 months of age

• on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

--------------------------------------------------------------------------------------------------------

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

Uses

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

• Recommended for repeated use.

Purpose

ANTISEPTIC

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

• Not recommended for infants

Other Information

• Store between 1℃-30℃ (33.8℉-86℉)

• Avoid freezing and excessive heat above 40℃ (104℉)

Inactive Ingredients

Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Polysorbate 80, Aloe barbadensis leaf extract, Fragrance

Description

Ethyl alcohol 70%

Active Ingredient

Ethyl alcohol 70%

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel


Structured Label Content

Warnings (WARNINGS)

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

--------------------------------------------------------------------------------------------------------

Do not use

• in children less than 2 months of age

• on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

--------------------------------------------------------------------------------------------------------

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

Uses

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

• Recommended for repeated use.

Purpose (PURPOSE)

ANTISEPTIC

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

• Not recommended for infants

Other Information

• Store between 1℃-30℃ (33.8℉-86℉)

• Avoid freezing and excessive heat above 40℃ (104℉)

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Polysorbate 80, Aloe barbadensis leaf extract, Fragrance

Active Ingredient (ACTIVE INGREDIENT)

Ethyl alcohol 70%

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

If swallowed, get medical help or contact a Poison Control Center right away.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)