Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID aa9b5663-2684-4d75-9d03-73718c097806

Route

TOPICAL

Published

Effective Date 2014-06-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (65 mL)

Inactive Ingredients

Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Peg-12 Dimethicone (300 Cst) Propylene Glycol .alpha.-tocopherol Acetate Trolamine Fd&c Blue No. 1 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-06-01

Description

Inactive Ingredients carbomer 940, PEG-12 dimethicone, tocopheryl acetate, triethanomaline, blue 1, water

Medication Information

Warnings and Precautions

Warning

For external use only

Flammable, keep away from fire or flame.

Indications and Usage

Uses

hand sanitizer to help

reduce bacteria on skin

Dosage and Administration

Directions

Put a dime sized drop onto hands

and rub together briskly until dry.

Description

Inactive Ingredients carbomer 940, PEG-12 dimethicone, tocopheryl acetate, triethanomaline, blue 1, water

Section 44425-7

Other information

Store below 110 F (43 C)

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison

Control Center right away.

Section 50566-9

Stop use and ask a doctor if

irritation, excessive redness

or rash develops.

Section 50570-1

Do not use in or near the eyes.

In case of contact, rinse eyes

thoroughly with water.

Section 51727-6

Inactive Ingredients

carbomer 940, PEG-12

dimethicone, tocopheryl

acetate, triethanomaline,

blue 1, water

Section 51945-4

Section 55105-1

Purpose Antimicrobial

Section 55106-9

Active Ingredient

Ethyl Alcohol, 65 % v/v

Structured Label Content

Indications and Usage (34067-9)

Uses

hand sanitizer to help

reduce bacteria on skin

Dosage and Administration (34068-7)

Directions

Put a dime sized drop onto hands

and rub together briskly until dry.

Warnings and Precautions (34071-1)

Warning

For external use only

Flammable, keep away from fire or flame.

Section 44425-7 (44425-7)

Other information

Store below 110 F (43 C)

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison

Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

irritation, excessive redness

or rash develops.

Section 50570-1 (50570-1)

Do not use in or near the eyes.

In case of contact, rinse eyes

thoroughly with water.

Section 51727-6 (51727-6)

Inactive Ingredients

carbomer 940, PEG-12

dimethicone, tocopheryl

acetate, triethanomaline,

blue 1, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose Antimicrobial

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol, 65 % v/v

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-12 DIMETHICONE (300 CST)", "unii": "ZEL54N6W95", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses hand sanitizer to help reduce bacteria on skin", "34068-7": "Directions Put a dime sized drop onto hands and rub together briskly until dry.", "34071-1": "Warning For external use only Flammable, keep away from fire or flame.", "44425-7": "Other information Store below 110 F (43 C)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation, excessive redness or rash develops.", "50570-1": "Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "51727-6": "Inactive Ingredients carbomer 940, PEG-12 dimethicone, tocopheryl acetate, triethanomaline, blue 1, water", "55105-1": "Purpose Antimicrobial", "55106-9": "Active Ingredient Ethyl Alcohol, 65 % v/v"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:48.278249 · Updated: 2026-03-14T22:53:45.950699