drug fact

drug fact
SPL v5
SPL
SPL Set ID c76955a3-883f-4cec-8d1b-616184204308
Route
topical
Published
Effective Date 2015-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (65 mL)
Inactive Ingredients
water phenoxyethanol carbomer copolymer type a sodium hydride dmdm hydantoin fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Pill Appearance
Color: red Color: pink Color: green Color: orange Color: purple Color: blue
Marketing Status
otc monograph not final active Since 2015-04-17
Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Medication Information

Uses

To decrease bacteria on the skin.

Purpose

Antiseptic

Directions

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

Children under 6 years of age should be supervised when using this product.

Other Information

do not store above 104F (40C)

may discolor certain fa surfaces.

Description

Ethyl Alcohol 65%

Section 51945-4

Warning

For external use only.

When using this product avoid contact with eyes.In case of contact flush eyes thoroughly with water.

Flammable.

Keep away from heat and flame.



Stop use and consult a doctor

if irritation and redness develop and persist for more than 72 hours.

Active Ingredient

Ethyl Alcohol 65%

Inactive Ingredient

WATER,PHENOXYETHANOL,CARBOMER COPOLYMER TYPE A,SODIUM HYDRIDE,DMDM HYDANTOIN ,FD&C BLUE NO. 1,FD&C YELLOW NO. 5

Keep Out of Reach of Children.

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

Structured Label Content

Uses

To decrease bacteria on the skin.

Purpose

Antiseptic

Directions

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

Children under 6 years of age should be supervised when using this product.

Other Information

do not store above 104F (40C)

may discolor certain fa surfaces.

Section 51945-4 (51945-4)

Warning

For external use only.

When using this product avoid contact with eyes.In case of contact flush eyes thoroughly with water.

Flammable.

Keep away from heat and flame.



Stop use and consult a doctor

if irritation and redness develop and persist for more than 72 hours.

Active Ingredient

Ethyl Alcohol 65%

Inactive Ingredient

WATER,PHENOXYETHANOL,CARBOMER COPOLYMER TYPE A,SODIUM HYDRIDE,DMDM HYDANTOIN ,FD&C BLUE NO. 1,FD&C YELLOW NO. 5

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:56.091652 · Updated: 2026-03-14T22:53:59.906934