Hand Sanitizer

SPL v1

SPL

SPL Set ID 8f346e43-3210-448f-a39e-5882bb5e9397

Route

TOPICAL

Published

Effective Date 2020-05-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.7 mL)

Inactive Ingredients

Water Glycerin Capryloyl/caproyl Methyl Glucamide Carbomer Homopolymer, Unspecified Type .alpha.-tocopherol .alpha.-tocopherol Acetate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-15

Description

Ethyl alcohol 70%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 70%

Uses

to decrease bacteria on the skin that could cause disease recommended for repeated use.

Warnings

For external use only: hands

Flammable, keep away from fire or flame

Directions

Wet hands thorouughly with product and allow to dry without wiping / for children under 6, use only under adult supervision/ not recommended for infacts

Drug Facts

Active Ingredient

Ethyl alcohol 70%

Other Information

do not store above 105 F / may discolor some fabrics / harmful to wood finishes and plastics

Inactive Ingredients

Water, glycerin/caprylate carbopol, vitamin E,Water, glycerin, caprate, tocopheryl acetate, acrylates/C10-30 alkyl acrylates crosspolymer

Package Labeling:240ml

Package Labeling:400ml

Package Labeling:580ml

Stop Use and Ask A Doctor

of irritation and redness develop/ condition persosts for more than 72 hours

When Using This Product

keep out of eyes, In case of contact with eyes, flush thoroughly with water./ avoid contact with broken skin/ do not inhale or ingest.

Keep Out of Reach of Children

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

Structured Label Content

Uses

to decrease bacteria on the skin that could cause disease recommended for repeated use.

Purpose

Antiseptic

Warnings

For external use only: hands

Flammable, keep away from fire or flame

Directions

Wet hands thorouughly with product and allow to dry without wiping / for children under 6, use only under adult supervision/ not recommended for infacts

Drug Facts

Active Ingredient (Active ingredient)

Ethyl alcohol 70%

Other Information

do not store above 105 F / may discolor some fabrics / harmful to wood finishes and plastics

Inactive Ingredients

Water, glycerin/caprylate carbopol, vitamin E,Water, glycerin, caprate, tocopheryl acetate, acrylates/C10-30 alkyl acrylates crosspolymer

Package Labeling:240ml

Package Labeling:400ml

Package Labeling:580ml

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

of irritation and redness develop/ condition persosts for more than 72 hours

When Using This Product (When using this product )

keep out of eyes, In case of contact with eyes, flush thoroughly with water./ avoid contact with broken skin/ do not inhale or ingest.

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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLOYL/CAPROYL METHYL GLUCAMIDE", "unii": "0451R360HR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "0.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "to decrease bacteria on the skin that could cause disease recommended for repeated use.", "Purpose": "Antiseptic", "Warnings": "For external use only: hands Flammable, keep away from fire or flame", "Directions": "Wet hands thorouughly with product and allow to dry without wiping / for children under 6, use only under adult supervision/ not recommended for infacts", "Active ingredient": "Ethyl alcohol 70%", "Other Information": "do not store above 105 F / may discolor some fabrics / harmful to wood finishes and plastics", "Inactive Ingredients": "Water, glycerin/caprylate carbopol, vitamin E,Water, glycerin, caprate, tocopheryl acetate, acrylates/C10-30 alkyl acrylates crosspolymer", "Stop use and ask a doctor": "of irritation and redness develop/ condition persosts for more than 72 hours", "When using this product ": "keep out of eyes, In case of contact with eyes, flush thoroughly with water./ avoid contact with broken skin/ do not inhale or ingest.", "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: 2026-02-15T11:57:42.583685 · Updated: 2026-03-14T22:56:56.523889