SPL v1
SPL
SPL Set ID a4eec32a-2d99-34f4-e053-2995a90a3d3c
Route
TOPICAL
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
.alpha.-tocopherol Acetate, D- Glycerin Water Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Dexpanthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-18
Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic; Hand Sanitizer

Medication Information

Purpose

Antiseptic; Hand Sanitizer

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Uses

To decrease bacteria on the skin that could cause disease. Reccomended for repeated use. For use when soap and water are not available.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

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

Warnings

For external use only: Hands. Flammable, keep aware from fire or flame.

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.

Do Not Use

In children less than 2 months of age. On open skin or wounds.

Active Ingredient

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Other Information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Purified Water USP, Glycerin, Tocopheryl Acetate (Vitamin E), Panthenol (Vitamin B-6), Polyacrylate Crosspolymer-6, Fragerence

Packaging Label Principal Display Panel

59 ML NDC Code 75396-315-17

FRONT

BACK

118ML NDC Code 75396-315-18

FRONT

BACK

3785ML NDC Code 75396-315-19

FRONT

BACK

Structured Label Content

Uses

To decrease bacteria on the skin that could cause disease. Reccomended for repeated use. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Purpose

Antiseptic; Hand Sanitizer

Warnings

For external use only: Hands. Flammable, keep aware from fire or flame.

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.

Do Not Use (Do not use)

In children less than 2 months of age. On open skin or wounds.

Active Ingredient

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Other Information (Other information)

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Purified Water USP, Glycerin, Tocopheryl Acetate (Vitamin E), Panthenol (Vitamin B-6), Polyacrylate Crosspolymer-6, Fragerence

Packaging Label Principal Display Panel (Packaging Label - Principal Display Panel)

59 ML NDC Code 75396-315-17

FRONT

BACK

118ML NDC Code 75396-315-18

FRONT

BACK

3785ML NDC Code 75396-315-19

FRONT

BACK

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:37.113861 · Updated: 2026-03-14T22:56:50.267871