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

Purpose

ANTISEPTIC

Description

Ethyl Alcohol 75% v/v


Medication Information

Warnings

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

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Do not use

• in children less than 2 months of age

• on open skin wounds

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

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

Uses

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

Purpose

ANTISEPTIC

Directions

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

■ Do not flush

■ Children under 2 years ask a doctor before use

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

Description

Ethyl Alcohol 75% v/v

Active Ingredient

Ethyl Alcohol 75% v/v

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

Purpose (PURPOSE)

ANTISEPTIC

Directions

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

■ Do not flush

■ Children under 2 years ask a doctor before use

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

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 75% v/v

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

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