Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 8d186b14-60fa-4050-bc6b-9e0a88f0fe82
Route
TOPICAL
Published
Effective Date 2012-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Propylene Glycol Trolamine Lactose Hypromelloses Cellulose, Microcrystalline .alpha.-tocopherol Acetate Fd&c Yellow No. 5 Fd&c Red No. 4 D&c Red No. 33 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: red Color: pink Color: green Color: orange Color: purple Color: blue
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-06-14
Description

Ethyl Alcohol 63%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 63%

Uses
To decrease bacteria on the skin.
Section 51945-4

Enter section text here

Warning
For external use only.



Flammable.

Keep away from heat and flame.



When using this product

■ Avoid contact with eyes. If contact occurs, flush eyes with water.

■ Avoid contact with broken skin.



Stop use and consult a doctor

if irritation and redness develop and persist for more than 72 hours.
Directions
■ Wet hands with product and allow to dry without wiping.

■  Not recommended for infants.
Active Ingredient
Ethyl Alcohol 63%

Other Information
■ Store at 68 o to 77 oF (20 o to 25 oc).

■ Do not store above 105 oF.

■ May discolor some fabrics.

■ Harmful to wood finishes and plastics.
Inactive Ingredient
Alcohol Denat., Water, Propylene Glycol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Jojoba Esters, Tocopheryl Acetate, Blue 1(CI 42090), Red 33(CI 17200), Red 4(CI 14700).

Yellow 5(CI 19140),
Keep Out of Reach of Children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.



Structured Label Content

Uses
To decrease bacteria on the skin.
Section 51945-4 (51945-4)

Enter section text here

Purpose

Antiseptic

Warning
For external use only.



Flammable.

Keep away from heat and flame.



When using this product

■ Avoid contact with eyes. If contact occurs, flush eyes with water.

■ Avoid contact with broken skin.



Stop use and consult a doctor

if irritation and redness develop and persist for more than 72 hours.
Directions
■ Wet hands with product and allow to dry without wiping.

■  Not recommended for infants.
Active Ingredient
Ethyl Alcohol 63%

Other Information
■ Store at 68 o to 77 oF (20 o to 25 oc).

■ Do not store above 105 oF.

■ May discolor some fabrics.

■ Harmful to wood finishes and plastics.
Inactive Ingredient
Alcohol Denat., Water, Propylene Glycol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Jojoba Esters, Tocopheryl Acetate, Blue 1(CI 42090), Red 33(CI 17200), Red 4(CI 14700).

Yellow 5(CI 19140),
Keep Out of Reach of Children. (Keep out of reach of children.)
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.



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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:30.515954 · Updated: 2026-03-14T22:53:15.110984