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SPL v1

SPL

SPL Set ID 7b73cddd-f145-4751-83dd-560154709f5e

Route

TOPICAL

Published

Effective Date 2020-04-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Glycerin Propylene Glycol Water Carbomer 934 Aloe Vera Whole Alpha-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-29

Description

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Use

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Section 42229-5

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if skin irritation develops

Section 50567-7

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

Avoid contact with broken skin

Do not inhale or ingest

Section 51945-4

Warnings

For external use only.

Flammable

May discolor some fabrics

Harmful to wood finishes and plastics

Directions

Wet hands thoroughly with product and allow to dry without wiping
For children under 6 years of age, use only under adult supervision

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients

Water, triethanolamin, carbomer, aloe barbadensis (aloe vera) gel, fragrance, propylene glycol, glycerin, tocopheryl acetate (Vitamin E)

Structured Label Content

Use

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation develops

Section 50567-7 (50567-7)

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

Avoid contact with broken skin

Do not inhale or ingest

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For external use only.

Flammable

May discolor some fabrics

Harmful to wood finishes and plastics

Directions

Wet hands thoroughly with product and allow to dry without wiping
For children under 6 years of age, use only under adult supervision

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Water, triethanolamin, carbomer, aloe barbadensis (aloe vera) gel, fragrance, propylene glycol, glycerin, tocopheryl acetate (Vitamin E)

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA WHOLE", "unii": "KIZ4X2EHYX", "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": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "To decrease bacteria on the skin that could cause disease Recommended for repeated use", "42229-5": "NA", "50565-1": "Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.", "50566-9": "Stop use and ask a doctor if skin irritation develops", "50567-7": "When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin Do not inhale or ingest", "Purpose": "Antimicrobial", "Warnings": "For external use only. Flammable May discolor some fabrics Harmful to wood finishes and plastics", "Directions": "Wet hands thoroughly with product and allow to dry without wiping For children under 6 years of age, use only under adult supervision", "Active Ingredient(s)": "Ethyl Alcohol 70% v/v", "Inactive ingredients": "Water, triethanolamin, carbomer, aloe barbadensis (aloe vera) gel, fragrance, propylene glycol, glycerin, tocopheryl acetate (Vitamin E)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:23.145122 · Updated: 2026-03-14T22:56:31.394385