suppress hand sanitizer

SPL v2

SPL

SPL Set ID abb0a9ae-24bb-edbd-e053-2995a90a1265

Route

topical

Published

Effective Date 2020-03-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

sodium hydroxide aloe vera leaf peg-40 castor oil carbomer 940 water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-30

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 75% v/v. Purpose: Antiseptic

Medication Information

Warnings

For external use only. Do not inhale or ingest. Flammable. Keep away from heat or flame when using this product.

Purpose

Antiseptic, Hand Sanitizer

Directions

Apply to hands thoroughly and rub vigorously until dry.
For children under 6 years, use only with adult supervision.
Not recommended for infants.

Other Information

Do not store above 104F (40C)
May discolor some fabrics
harmful to some wood finishes

Inactive Ingredients

purified water USP

PEG-40 hydrogenated castor oil

carbomer

sodium hydroxide

aloe vera extract

Description

Alcohol 75% v/v. Purpose: Antiseptic

Use

to decrease bacteria on the skin.

Section 50565-1

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

Section 50566-9

Stop use and ask a physician if skin irritation occurs.

Section 50567-7

When using this product keep away from eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

Do Not Use

in children less than 2 months of age
on open skin wounds

Distributed By:

Distributed by: HD Group LLC 335 N Edgewood Ln, Suite 130 Eagle, ID 83616

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

500 mL NDC: 77343-111-01

Structured Label Content

Warnings

For external use only. Do not inhale or ingest. Flammable. Keep away from heat or flame when using this product.

Purpose

Antiseptic, Hand Sanitizer

Directions

Apply to hands thoroughly and rub vigorously until dry.
For children under 6 years, use only with adult supervision.
Not recommended for infants.

Other Information (Other information)

Do not store above 104F (40C)
May discolor some fabrics
harmful to some wood finishes

Inactive Ingredients (Inactive ingredients)

purified water USP

PEG-40 hydrogenated castor oil

carbomer

sodium hydroxide

aloe vera extract

Use

to decrease bacteria on the skin.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a physician if skin irritation occurs.

Section 50567-7 (50567-7)

When using this product keep away from eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

Do Not Use (Do not use)

in children less than 2 months of age
on open skin wounds

Distributed By:

Distributed by: HD Group LLC 335 N Edgewood Ln, Suite 130 Eagle, ID 83616

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel (Package Label - Principal Display Panel)

500 mL NDC: 77343-111-01

Advanced Ingredient Data

[{"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-40 CASTOR OIL", "unii": "4ERD2076EF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "to decrease bacteria on the skin.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.", "50566-9": "Stop use and ask a physician if skin irritation occurs.", "50567-7": "When using this product keep away from eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "For external use only. Do not inhale or ingest. Flammable. Keep away from heat or flame when using this product.", "Directions": "Apply to hands thoroughly and rub vigorously until dry. For children under 6 years, use only with adult supervision. Not recommended for infants.", "Do not use": "in children less than 2 months of age on open skin wounds", "Distributed By:": "Distributed by: HD Group LLC 335 N Edgewood Ln, Suite 130 Eagle, ID 83616", "Other information": "Do not store above 104F (40C) May discolor some fabrics harmful to some wood finishes", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "purified water USP PEG-40 hydrogenated castor oil carbomer sodium hydroxide aloe vera extract", "Package Label - Principal Display Panel": "500 mL NDC: 77343-111-01"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:59.098479 · Updated: 2026-03-14T23:00:16.210127