Instant Hand Antiseptic

SPL v2

SPL

SPL Set ID 9aca3f89-cdde-430c-8eb6-43a3ac3fc0df

Route

TOPICAL

Published

Effective Date 2021-10-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Water Aloe Vera Leaf Glycerin Propylene Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-10-01

Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

Directions

Not recommended for infants.

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

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

Active Ingredient

Ethyl Alcohol 62%

Other Information

Do not store above 110°F. May discolor some fabrics.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance.

Principal Display Panel 53 Ml Bottle Label

Wellstar

Instant Hand Antiseptic

62% w/w Ethyl Alcohol

1.9 FL OZ / 53 mL

Distributed by:

ASP Global, LLC

7800 Third Flag Parkway,

Austell, GA 30168, USA

Rev 00

Structured Label Content

Uses

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Purpose

Antiseptic

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

Directions

Not recommended for infants.

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

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

Active Ingredient

Ethyl Alcohol 62%

Other Information

Do not store above 110°F. May discolor some fabrics.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance.

Principal Display Panel 53 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label)

Wellstar

Instant Hand Antiseptic

62% w/w Ethyl Alcohol

1.9 FL OZ / 53 mL

Distributed by:

ASP Global, LLC

7800 Third Flag Parkway,

Austell, GA 30168, USA

Rev 00

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand washing to decrease bacteria on the skin. Recommended for repeated use.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help.", "50566-9": "Stop use and ask a doctor if irritation or rash appears and lasts.", "50567-7": "When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "Purpose": "Antiseptic", "Warnings": "Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.", "Directions": "Not recommended for infants. Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.", "Active Ingredient": "Ethyl Alcohol 62%", "Other Information": "Do not store above 110°F. May discolor some fabrics.", "Inactive Ingredients": "Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance.", "PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label": "Wellstar Instant Hand Antiseptic 62% w/w Ethyl Alcohol 1.9 FL OZ / 53 mL Distributed by: ASP Global, LLC 7800 Third Flag Parkway, Austell, GA 30168, USA Rev 00"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:39.339152 · Updated: 2026-03-14T23:05:32.543899