Hand Sanitizer

SPL v6

SPL

SPL Set ID b48f9afa-1634-e63e-e053-2a95a90a32bf

Route

TOPICAL

Published

Effective Date 2009-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (64.325 g)

Inactive Ingredients

Aminomethylpropanol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2009-03-28

Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses

for sanitizing hands to help reduce bacteria on the skin.
for deodorizing hands to help reduce odors on the skin.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

Directions

rinse solids & slime from hands if possible.
pat dry.
put a thumbnail size amount in your palm and rub hands together briskly until dry.
repeat as needed.
children under 6 months: As a doctor

Drug Facts

Drug Facts

Other Information

Warning: Flammable

do not use near open flame or heat source
do not store above 110°F (43°C)
protect this product from excessive heat and direct sun
may discolor certain fabrics or surfaces

Active Ingredients

Ethyl Alcohol 64.325%

Inactive Ingredients

deionized water, glycerin, acrylates/c10-30 alkyl acrylate crosspolymer, aminomethyl propanol, and fragrance.

Questions Or Comments?

Call toll free1-800-368-7327

Principal Display Panel Bottle Label

60ml NDC: 52854-600-01

119ml NDC: 52854-600-02

237ml NDC: 52854-600-03

250ml NDC: 52854-600-04

1000ml NDC: 52854-600-05

3785ml NDC: 52854-600-06

Structured Label Content

Uses

for sanitizing hands to help reduce bacteria on the skin.
for deodorizing hands to help reduce odors on the skin.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Antiseptic

Warnings

For external use only

Directions

rinse solids & slime from hands if possible.
pat dry.
put a thumbnail size amount in your palm and rub hands together briskly until dry.
repeat as needed.
children under 6 months: As a doctor

Drug Facts

Drug Facts

Other Information

Warning: Flammable

do not use near open flame or heat source
do not store above 110°F (43°C)
protect this product from excessive heat and direct sun
may discolor certain fabrics or surfaces

Active Ingredients

Ethyl Alcohol 64.325%

Inactive Ingredients

deionized water, glycerin, acrylates/c10-30 alkyl acrylate crosspolymer, aminomethyl propanol, and fragrance.

Questions Or Comments? (Questions or Comments?)

Call toll free1-800-368-7327

Principal Display Panel Bottle Label (Principal Display Panel - Bottle Label)

60ml NDC: 52854-600-01

119ml NDC: 52854-600-02

237ml NDC: 52854-600-03

250ml NDC: 52854-600-04

1000ml NDC: 52854-600-05

3785ml NDC: 52854-600-06

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "64.325", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for sanitizing hands to help reduce bacteria on the skin. for deodorizing hands to help reduce odors on the skin.", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin", "Purpose": "Antiseptic", "Warnings": "For external use only", "Directions": "rinse solids & slime from hands if possible. pat dry. put a thumbnail size amount in your palm and rub hands together briskly until dry. repeat as needed. children under 6 months: As a doctor", "Drug Facts": "Drug Facts", "Other Information": "Warning: Flammable do not use near open flame or heat source do not store above 110°F (43°C) protect this product from excessive heat and direct sun may discolor certain fabrics or surfaces", "Active Ingredients": "Ethyl Alcohol 64.325%", "Inactive Ingredients": "deionized water, glycerin, acrylates/c10-30 alkyl acrylate crosspolymer, aminomethyl propanol, and fragrance.", "Questions or Comments?": "Call toll free1-800-368-7327", "Principal Display Panel - Bottle Label": "60ml NDC: 52854-600-01 119ml NDC: 52854-600-02 237ml NDC: 52854-600-03 250ml NDC: 52854-600-04 1000ml NDC: 52854-600-05 3785ml NDC: 52854-600-06"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:11.916370 · Updated: 2026-03-14T23:13:23.763125