77731-083/ab0035lz-yel

SPL v1

SPL

SPL Set ID a67b423f-dac6-4f46-a7d3-dfcbc2dbbc4b

Route

TOPICAL

Published

Effective Date 2020-09-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Carbomer 940 Trolamine Water Aloe Vera Leaf .alpha.-tocopherol Acetate Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-09-17

Description

Ethyl Alcohol 75% v/v

Medication Information

Description

Ethyl Alcohol 75% v/v

Use

Decrease bacteria on skin that could cause diseases

Recommended for repeated use

Section 51945-4

Section 55105-1

Purpose:

Antimicrobial

Warnings

For external use only. Flammable, keep way from flame or fire

Directions

Spread product on hands thoroughly and allow to dry, do not wipe off
For children under 6, use under adult supervision
Not recommended for use with infants

Other Information

Do not store above 105F (40.6C)

May discolor some fabrics

Harmful to plastics and wood finishes

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients

Water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance, Yellow 5 (CI19140)

When Using This Product

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water

Do not ingest or inhale

Avoid contact with broken skin

Stop Use and Ask A Doctor

if irrigation and redness develop or if condition persists for more than 72 hours

Keep Out of Reach of Children

if swallowed, get medical help or contact a Poison Control Center immediately

Structured Label Content

Use

Decrease bacteria on skin that could cause diseases

Recommended for repeated use

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Antimicrobial

Warnings

For external use only. Flammable, keep way from flame or fire

Directions

Spread product on hands thoroughly and allow to dry, do not wipe off
For children under 6, use under adult supervision
Not recommended for use with infants

Other Information (Other information)

Do not store above 105F (40.6C)

May discolor some fabrics

Harmful to plastics and wood finishes

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance, Yellow 5 (CI19140)

When Using This Product (When using this product)

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water

Do not ingest or inhale

Avoid contact with broken skin

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

if irrigation and redness develop or if condition persists for more than 72 hours

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

if swallowed, get medical help or contact a Poison Control Center immediately

Advanced Ingredient Data

[{"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "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": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Decrease bacteria on skin that could cause diseases Recommended for repeated use", "55105-1": "Purpose: Antimicrobial", "Warnings": "For external use only. Flammable, keep way from flame or fire", "Directions": "Spread product on hands thoroughly and allow to dry, do not wipe off For children under 6, use under adult supervision Not recommended for use with infants", "Other information": "Do not store above 105F (40.6C) May discolor some fabrics Harmful to plastics and wood finishes", "Active Ingredient(s)": "Ethyl Alcohol 75% v/v", "Inactive ingredients": "Water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance, Yellow 5 (CI19140)", "When using this product": "When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water Do not ingest or inhale Avoid contact with broken skin", "Stop use and ask a doctor": "if irrigation and redness develop or if condition persists for more than 72 hours", "Keep out of reach of children": "if swallowed, get medical help or contact a Poison Control Center immediately"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:45.753697 · Updated: 2026-03-14T22:58:28.205910