Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID d183e8a2-7770-4468-9228-a5c8ea4ff9d2

Route

TOPICAL

Published

Effective Date 2013-07-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (62 g)

Inactive Ingredients

Water Glycerin Propylene Glycol Trolamine Aloe Vera Leaf Alpha-tocopherol Acetate D&c Red No. 33 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-07-15

Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses

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

Warnings

For external use only
Flammable, keep away from fire and flame
Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances

Directions

Rub dime sized amount between hands until dry
Supervise children in the use of this product
in the case of eye contact, rinse eyes thoroughly with water

Package Label

Active Ingredient

Ethyl Alcohol 62%

Other Information

Store below 105F
May discolor some fabrics

Inactive Ingredients

Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum), DC Red 33, FDC Blue 1

When Using This Product

Avoid the eyes and mucous membranes
In the case of eyes or mucous membrane contact; rinse area thoroughly with water Use only as directed

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

If swallowed contact a doctor or Poison Control Center immediately.

Structured Label Content

Uses

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

Purpose

Antiseptic

Warnings

For external use only
Flammable, keep away from fire and flame
Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances

Directions

Rub dime sized amount between hands until dry
Supervise children in the use of this product
in the case of eye contact, rinse eyes thoroughly with water

Package Label

Active Ingredient

Ethyl Alcohol 62%

Other Information (Other information)

Store below 105F
May discolor some fabrics

Inactive Ingredients

Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum), DC Red 33, FDC Blue 1

When Using This Product (When using this product)

Avoid the eyes and mucous membranes
In the case of eyes or mucous membrane contact; rinse area thoroughly with water Use only as directed

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

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

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

If swallowed contact a doctor or Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For handwashing to decrease bacteria on the skin Recommended for repeated use", "Purpose": "Antiseptic", "Warnings": "For external use only Flammable, keep away from fire and flame Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances", "Directions": "Rub dime sized amount between hands until dry Supervise children in the use of this product in the case of eye contact, rinse eyes thoroughly with water", "Active Ingredient": "Ethyl Alcohol 62%", "Other information": "Store below 105F May discolor some fabrics", "Inactive Ingredients": "Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum), DC Red 33, FDC Blue 1", "When using this product": "Avoid the eyes and mucous membranes In the case of eyes or mucous membrane contact; rinse area thoroughly with water Use only as directed", "Stop use and ask a doctor if": "Condition worsens Redness or irritation develops If condition persists for more than 3 days", "Keep out of reach of children": "If swallowed contact a doctor or Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:49.357792 · Updated: 2026-03-14T22:53:46.796959