Hand Sanitizer

SPL v1

SPL

SPL Set ID 8ed7351b-fcde-464c-b95a-6cf48d1e4429

Route

TOPICAL

Published

Effective Date 2020-05-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Water Carbomer Homopolymer, Unspecified Type Trolamine Glycerin Propylene Glycol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-01

Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses

To decrease bacteria on the skin when water, soap & towel are not available – Recommended for repeated use.

Section 42229-5

Drug Facts

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 if irritation or redness develop and last more than 72 hours.

Section 50567-7

When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not use on broken or irritated skin.

Warnings

For external use only.

Directions

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Questions?

Call +1 786-631-7514

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information

Do not store above 105 °F (40 °C).
May discolor certain wood surfaces.

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice.

Principal Display Panel 500 Ml Bottle Label

PureHand

HAND SANITIZER

EXTRA STRENGTH

NEW FORMULA

KILLS 99.9% OF ILLNESS

CAUSING GERMS

NEW ADVANCE STRENGTH

70% ETHYL ALCOHOL

16.907 FL. OZ. (500 ml)

Structured Label Content

Uses

To decrease bacteria on the skin when water, soap & towel are not available – 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 or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develop and last more than 72 hours.

Section 50567-7 (50567-7)

When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not use on broken or irritated skin.

Purpose

Antiseptic

Warnings

For external use only.

Directions

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Questions?

Call +1 786-631-7514

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information (Other information)

Do not store above 105 °F (40 °C).
May discolor certain wood surfaces.

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice.

Principal Display Panel 500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 500 ml Bottle Label)

PureHand

HAND SANITIZER

EXTRA STRENGTH

NEW FORMULA

KILLS 99.9% OF ILLNESS

CAUSING GERMS

NEW ADVANCE STRENGTH

70% ETHYL ALCOHOL

16.907 FL. OZ. (500 ml)

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "carbomer homopolymer, unspecified type", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "trolamine", "unii": "9O3K93S3TK", "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": "aloe vera leaf", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "To decrease bacteria on the skin when water, soap & towel are not available – Recommended for repeated use.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or redness develop and last more than 72 hours.", "50567-7": "When using this product keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not use on broken or irritated skin.", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.", "Questions?": "Call +1 786-631-7514", "Active Ingredient": "Ethyl Alcohol 70% v/v", "Other information": "Do not store above 105 °F (40 °C). May discolor certain wood surfaces.", "Inactive Ingredients": "water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice.", "PRINCIPAL DISPLAY PANEL - 500 ml Bottle Label": "PureHand HAND SANITIZER EXTRA STRENGTH NEW FORMULA KILLS 99.9% OF ILLNESS CAUSING GERMS NEW ADVANCE STRENGTH 70% ETHYL ALCOHOL 16.907 FL. OZ. (500 ml)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:28.862385 · Updated: 2026-03-14T22:56:40.798179