SPL v1
SPL
SPL Set ID a530d5c7-e8bd-4c8e-9358-76c6799a6fb3
Route
TOPICAL
Published
Effective Date 2013-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (540.26 g)
Inactive Ingredients
Aloe Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) D&c Green No. 5 D&c Yellow No. 10 Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-03-27
Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

For handwashing to decrease bacteria on skin without soap and water.

Section 42229-5

Drug Facts

Section 50566-9

Stop use, ask doctor if irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use in eyes, if this happens, rinse thoroughly with water.

Warnings

For external use only. Flammable, keep away from fire or flame.

Directions
  • wet hands & wrists thoroughly with product and allow to dry without wiping
Active Ingredient

Ethyl Alcohol 66.5%

Inactive Ingredients

aloe vera, carbomer, D&C green # 5, D&C yellow # 10, fragrance, purified water, triethanolamine

Principal Display Panel – Pouch

NDC 57685-7110-0

APEX

ANTISEPTIC

Instant Hand

Sanitizer

Fresh Scent

with Aloe Vera

0.0570 fl.oz. (1.68 mL)

MFD for APEX SANITATION, LLC.

Detroit, MI 48228 800-281-1878

www.ApexAntiseptic.com

Structured Label Content

Use

For handwashing to decrease bacteria on skin without soap and water.

Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

Stop use, ask doctor if irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use in eyes, if this happens, rinse thoroughly with water.

Purpose

Antiseptic

Warnings

For external use only. Flammable, keep away from fire or flame.

Directions
  • wet hands & wrists thoroughly with product and allow to dry without wiping
Active Ingredient (Active ingredient)

Ethyl Alcohol 66.5%

Inactive Ingredients (Inactive ingredients)

aloe vera, carbomer, D&C green # 5, D&C yellow # 10, fragrance, purified water, triethanolamine

Principal Display Panel – Pouch (PRINCIPAL DISPLAY PANEL – Pouch)

NDC 57685-7110-0

APEX

ANTISEPTIC

Instant Hand

Sanitizer

Fresh Scent

with Aloe Vera

0.0570 fl.oz. (1.68 mL)

MFD for APEX SANITATION, LLC.

Detroit, MI 48228 800-281-1878

www.ApexAntiseptic.com

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:36.696827 · Updated: 2026-03-14T22:53:27.452907