Alcohol Based Foaming Hand Sanitizer

SPL v3

SPL

SPL Set ID bb623d85-4fc0-068d-e053-2995a90a7958

Route

TOPICAL

Published

Effective Date 2021-02-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Peg-8 Dimethicone Tert-butyl Alcohol Dimethicone Peg-7 Phosphate Peg-10 Dimethicone (600 Cst) Cocamidopropyl Pg-dimonium Chloride Phosphate Denatonium Benzoate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-02-15

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial Alcohol Based Foaming Hand Sanitizer Approval Label

Purpose

Antiseptic, Hand Sanitizer, Antimicrobial See Image "Alcohol Based Foaming Hand Sanitizer Approval Label"

Medication Information

Purpose

Antiseptic, Hand Sanitizer, Antimicrobial

See Image "Alcohol Based Foaming Hand Sanitizer Approval Label"

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial Alcohol Based Foaming Hand Sanitizer Approval Label

Use

• Hand sanitizing to help reduce microorganisms on the skin • Recommended for repeated use

• Use this product when soap and water are not available • Do not use when hands are visibly soiled

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Section 50565-1

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

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Section 50566-9

Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician.

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Section 50567-7

When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.

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

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Warnings

For external use only.

FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Directions

• Apply sufficient product in your palm to cover hands and rub hands together briskly until dry.

• For children under six years of age, hand sanitizer should only be used with adult supervision.
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Do Not Use

Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician.
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Other Information

FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial

Alcohol Based Foaming Hand Sanitizer Approval Label

Inactive Ingredients

Cocamidopropyl PG-Dimonium Chloride Phosphate, Denatonium benzoate, Dimethicone PEG-7 Phosphate, PEG-8 Dimethicone, PEG-10 Dimethicone, tert-Butyl alcohol, Water

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Package Label Principal Display Panel

1000 ml NDC: 71023-440-57

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Structured Label Content

Use

• Hand sanitizing to help reduce microorganisms on the skin • Recommended for repeated use

• Use this product when soap and water are not available • Do not use when hands are visibly soiled

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Section 50565-1 (50565-1)

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

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Section 50566-9 (50566-9)

Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician.

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.

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

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Purpose

Antiseptic, Hand Sanitizer, Antimicrobial

See Image "Alcohol Based Foaming Hand Sanitizer Approval Label"

Warnings

For external use only.

FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Directions

• Apply sufficient product in your palm to cover hands and rub hands together briskly until dry.

• For children under six years of age, hand sanitizer should only be used with adult supervision.
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Do Not Use

Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician.
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Other Information (Other information)

FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.
See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial

Alcohol Based Foaming Hand Sanitizer Approval Label

Inactive Ingredients (Inactive ingredients)

Cocamidopropyl PG-Dimonium Chloride Phosphate, Denatonium benzoate, Dimethicone PEG-7 Phosphate, PEG-8 Dimethicone, PEG-10 Dimethicone, tert-Butyl alcohol, Water

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

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

1000 ml NDC: 71023-440-57

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Advanced Ingredient Data

[{"name": "PEG-8 DIMETHICONE", "unii": "GIA7T764OD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TERT-BUTYL ALCOHOL", "unii": "MD83SFE959", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE PEG-7 PHOSPHATE", "unii": "WTP86Y84TV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PEG-10 DIMETHICONE (600 CST)", "unii": "8PR7V1SVM0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE", "unii": "H2KVQ74JM4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DENATONIUM BENZOATE", "unii": "4YK5Z54AT2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "• Hand sanitizing to help reduce microorganisms on the skin • Recommended for repeated use • Use this product when soap and water are not available • Do not use when hands are visibly soiled See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"", "50566-9": "Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician. See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"", "50567-7": "When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"", "Purpose": "Antiseptic, Hand Sanitizer, Antimicrobial See Image "Alcohol Based Foaming Hand Sanitizer Approval Label"", "Warnings": "For external use only. FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge. See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"", "Directions": "• Apply sufficient product in your palm to cover hands and rub hands together briskly until dry. • For children under six years of age, hand sanitizer should only be used with adult supervision. See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"", "Do Not Use": "Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician. See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"", "Other information": "FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge. See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"", "Active Ingredient(s)": "Ethyl Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial Alcohol Based Foaming Hand Sanitizer Approval Label", "Inactive ingredients": "Cocamidopropyl PG-Dimonium Chloride Phosphate, Denatonium benzoate, Dimethicone PEG-7 Phosphate, PEG-8 Dimethicone, PEG-10 Dimethicone, tert-Butyl alcohol, Water See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"", "Package Label - Principal Display Panel": "1000 ml NDC: 71023-440-57 See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label""}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:21.183580 · Updated: 2026-03-14T23:00:44.685211