Simple Hygiene Foaming Hand Sanitizer

SPL v4

SPL

SPL Set ID f2a4bdd0-f78b-4a62-b2d3-bb78e5788600

Route

TOPICAL

Published

Effective Date 2018-03-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (620 mg)

Inactive Ingredients

Glycereth-2 Cocoate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-09-01

Description

Ethanol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethanol 62%

Uses

For hand washing to decrease the bacteria on skin.
Recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire or flame.

Directions

For children under 6, use only under adult supervision
Pump a small amount of foam into palm of hand
Wet hands thoroughly with product and allow to dry without wiping

Do Not Use

in the eyes. In case of contact, flush eyes with water.

Active Ingredient

Ethanol 62%

Package Labeling:

Inactive Ingredients

glycereth-2-cocoate, PEG-10 acrylate/perfluorohexyethyl acrylate copolymer/perfluorohexyethyl alcohol, water

Stop Use and Ask A Doctor If

irritation and redness develop
condition persists for more than 72 hours

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

For hand washing to decrease the bacteria on skin.
Recommended for repeated use

Purpose

Antiseptic

Warnings

For external use only

Flammable, keep away from fire or flame.

Directions (DIRECTIONS)

For children under 6, use only under adult supervision
Pump a small amount of foam into palm of hand
Wet hands thoroughly with product and allow to dry without wiping

Do Not Use (Do not use)

in the eyes. In case of contact, flush eyes with water.

Active Ingredient (Active ingredient)

Ethanol 62%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

glycereth-2-cocoate, PEG-10 acrylate/perfluorohexyethyl acrylate copolymer/perfluorohexyethyl alcohol, water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation and redness develop
condition persists for more than 72 hours

Keep Out of Reach of Children. (Keep out of reach of children. )

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "GLYCERETH-2 COCOATE", "unii": "JWM00VS7HC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "620", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand washing to decrease the bacteria on skin. Recommended for repeated use", "Purpose": "Antiseptic", "Warnings": "For external use only Flammable, keep away from fire or flame.", "DIRECTIONS": "For children under 6, use only under adult supervision Pump a small amount of foam into palm of hand Wet hands thoroughly with product and allow to dry without wiping", "Do not use": "in the eyes. In case of contact, flush eyes with water.", "Active ingredient": "Ethanol 62%", "Inactive ingredients": "glycereth-2-cocoate, PEG-10 acrylate/perfluorohexyethyl acrylate copolymer/perfluorohexyethyl alcohol, water", "Stop use and ask a doctor if": "irritation and redness develop condition persists for more than 72 hours", "Keep out of reach of children. ": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:10.643732 · Updated: 2026-03-14T23:01:35.007581