drug facts

drug facts

SPL v1

SPL

SPL Set ID ac952f0f-0b76-4b4a-b03d-55117a6dea8e

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.

Active Ingredient

Active Ingredient

Ethyl Alcohol, 65 % v/v

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

Structured Label Content

Warnings and Precautions (34071-1)

Warning

For external use only

Flammable, keep away from fire or flame.

Active Ingredient (55106-9)

Active Ingredient

Ethyl Alcohol, 65 % v/v

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.

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

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: 2026-02-15T11:55:48.280019 · Updated: 2026-03-14T22:53:45.950699