Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID cdef3a60-d3f9-4a45-92a4-9935f8e5482d

Route

TOPICAL

Published

Effective Date 2009-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (65 mL)

Inactive Ingredients

Propylene Glycol Glycerin Polyoxyl 40 Hydrogenated Castor Oil Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2010-01-07

Description

Active Ingredient Alcohol 65%

Medication Information

Warnings and Precautions

Warnings

For external use only
Flammable, keep away from fire and flame

Indications and Usage

Use

For handwashing to decrease bacteria on the skin
Recommended for repeated use

Dosage and Administration

Directions

Spray on hands and rub together until dry
Supervise children in the use of this product
In the case of eye contact, rinse eyes thoroughly with water

Description

Active Ingredient Alcohol 65%

Section 42229-5

Other Information

Store below 105 F
May discolor some fabrics

Section 50565-1

Keep out of reach of children If swallowed contact a doctor or Poison Control Center immediately

Section 50566-9

Stop use and ask a doctor if

Condition worsens
Redness or irritation develops
If condition persists for more than 3 days

Section 50567-7

When using this product

Avoid the eyes and mucous membranes
In the case of eyes or mucous membrane contact, rinse area thoroughly with water

Section 51727-6

Inactive ingredients Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Fragrance, Water

Section 51945-4

Package Label

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Alcohol 65%

Structured Label Content

Indications and Usage (34067-9)

Use

For handwashing to decrease bacteria on the skin
Recommended for repeated use

Dosage and Administration (34068-7)

Directions

Spray on hands and rub together until dry
Supervise children in the use of this product
In the case of eye contact, rinse eyes thoroughly with water

Warnings and Precautions (34071-1)

Warnings

For external use only
Flammable, keep away from fire and flame

Section 42229-5 (42229-5)

Other Information

Store below 105 F
May discolor some fabrics

Section 50565-1 (50565-1)

Keep out of reach of children If swallowed contact a doctor or Poison Control Center immediately

Section 50566-9 (50566-9)

Stop use and ask a doctor if

Condition worsens
Redness or irritation develops
If condition persists for more than 3 days

Section 50567-7 (50567-7)

When using this product

Avoid the eyes and mucous membranes
In the case of eyes or mucous membrane contact, rinse area thoroughly with water

Section 51727-6 (51727-6)

Inactive ingredients Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Fragrance, Water

Section 51945-4 (51945-4)

Package Label

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Alcohol 65%

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use For handwashing to decrease bacteria on the skin Recommended for repeated use", "34068-7": "Directions Spray on hands and rub together until dry Supervise children in the use of this product In the case of eye contact, rinse eyes thoroughly with water", "34071-1": "Warnings For external use only Flammable, keep away from fire and flame", "42229-5": "Other Information Store below 105 F May discolor some fabrics", "50565-1": "Keep out of reach of children If swallowed contact a doctor or Poison Control Center immediately", "50566-9": "Stop use and ask a doctor if Condition worsens Redness or irritation develops If condition persists for more than 3 days", "50567-7": "When using this product Avoid the eyes and mucous membranes In the case of eyes or mucous membrane contact, rinse area thoroughly with water", "51727-6": "Inactive ingredients Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Fragrance, Water", "51945-4": "Package Label", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredient Alcohol 65%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:54:58.930708 · Updated: 2026-03-14T22:52:14.617580