Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0479f4af-249e-446f-b84a-c8bd101db586
Route
TOPICAL
Published
Effective Date 2020-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 1)
Inactive Ingredients
Water Cetylpyridinium Chloride Glycerin Caprylhydroxamic Acid Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

Ethyl Alcohol 75% v/v

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

Ethyl Alcohol 75% v/v

Uses

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.

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.

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ Do not flush

■ Children under 2 years ask a doctor before use

Active Ingredient

Ethyl Alcohol 75% v/v

Other Information

■ Read the directions and warnings before use

■ Store between 15-30℃(59-89℉)

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

Inactive Ingredients

Water, Cetylpyridinium chloride, Glycerin, Polysorbate, Caprylhydroxamic acid, Citric acid

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

Uses

Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.

Purpose (PURPOSE)

ANTISEPTIC

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.

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ Do not flush

■ Children under 2 years ask a doctor before use

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 75% v/v

Other Information (Other information)

■ Read the directions and warnings before use

■ Store between 15-30℃(59-89℉)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Cetylpyridinium chloride, Glycerin, Polysorbate, Caprylhydroxamic acid, Citric acid

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)