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SPL v1

SPL

SPL Set ID 390c6afd-e2c2-414c-e063-6294a90ae119

Route

TOPICAL

Published

Effective Date 2025-07-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Isopropyl Alcohol (331 mL)

Inactive Ingredients

Fd&c Green No. 3 Water Glycerin Methyl Salicylate Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-07-17

Description

Isopropyl alcohol (70% conc.)

Purpose

first aid antiseptic

Medication Information

Purpose

first aid antiseptic

Description

Isopropyl alcohol (70% conc.)

Section 51945-4

Warnings

For external use only; flammable, keep away from fire or flame, heat, spark, electrical

Directions

• clean effected area

• apply small amount of this product on the area 1-3 times daily

• May be covered with a sterile bandage

• If bandaged, let dry first

Other Information

• store at room temperature

• does not contain, nor is intended as a substitute for grain or ethyl alcohol will produce serious gastric disturbances if taken internally.

Active Ingredients

Isopropyl alcohol (70% conc.)

Indications & Usage

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

Inactive Ingredients

Purified Water, Methyl Salicylate, Glycerin, FD&C Green 3, FD&C Yellow 5

Stop Using This Product If

• condition persists or gets worse

When Using This Product

• do not get into eyes

• do not apply over large areas of the body

• do not use longer than one week unless directed by a doctor

Ask A Doctor Before Use If You Have

deep punctured wounds, animal bites or serious burns

Keep This and All Drugs Out of the Reach of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1222) immediately.

Structured Label Content

Section 51945-4 (51945-4)

Purpose (PURPOSE)

first aid antiseptic

Warnings

For external use only; flammable, keep away from fire or flame, heat, spark, electrical

Directions

• clean effected area

• apply small amount of this product on the area 1-3 times daily

• May be covered with a sterile bandage

• If bandaged, let dry first

Other Information (Other information)

• store at room temperature

• does not contain, nor is intended as a substitute for grain or ethyl alcohol will produce serious gastric disturbances if taken internally.

Active Ingredients

Isopropyl alcohol (70% conc.)

Indications & Usage (INDICATIONS & USAGE)

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

Inactive Ingredients

Purified Water, Methyl Salicylate, Glycerin, FD&C Green 3, FD&C Yellow 5

Stop Using This Product If (Stop using this product if)

• condition persists or gets worse

When Using This Product (When using this product)

• do not get into eyes

• do not apply over large areas of the body

• do not use longer than one week unless directed by a doctor

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep punctured wounds, animal bites or serious burns

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)

In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1222) immediately.

Advanced Ingredient Data

[{"name": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "331", "strengthDenominator": "473", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "METHYL SALICYLATE", "unii": "LAV5U5022Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "first aid antiseptic", "Warnings": "For external use only; flammable, keep away from fire or flame, heat, spark, electrical", "Directions": "• clean effected area • apply small amount of this product on the area 1-3 times daily • May be covered with a sterile bandage • If bandaged, let dry first", "Other information": "• store at room temperature • does not contain, nor is intended as a substitute for grain or ethyl alcohol will produce serious gastric disturbances if taken internally.", "Active Ingredients": "Isopropyl alcohol (70% conc.)", "INDICATIONS & USAGE": "first aid to help prevent the risk of infection in minor cuts, scrapes and burns", "Inactive Ingredients": "Purified Water, Methyl Salicylate, Glycerin, FD&C Green 3, FD&C Yellow 5", "Stop using this product if": "• condition persists or gets worse", "When using this product": "• do not get into eyes • do not apply over large areas of the body • do not use longer than one week unless directed by a doctor", "Ask a doctor before use if you have": "deep punctured wounds, animal bites or serious burns", "Keep this and all drugs out of the reach of children.": "In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1222) immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:32.501402 · Updated: 2026-03-14T23:09:21.323328