Antibacterial Antiseptic Spray

SPL v1

SPL

SPL Set ID a4cb8160-4e93-cad3-e053-2a95a90aba5e

Route

TOPICAL

Published

Effective Date 2020-05-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Water Polihexanide Hydrochloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-04

Description

Ethyl Alcohol 75%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

Antiseptic Spray to help reduce bacteria on the skin.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts

Section 55106-9

Ethyl Alcohol 75%

Warnings

1.Flammable,Keep away from fire or flame.

2.For external use only.

Directions

Place enough Product in your palm to cover hands and rub hands together briskyly until dry.

Children under 6 years of age should be supervised when using

Other Information

Store below 110°F.(43℃)·

May discolor certain fabrics or surfaces.

Inactive Ingredients

ALCOHOL(75%) , AQUA, POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE 0.36%-0.44%

When Using This Product

do not use in or near the eyes. In case of contact,rinse eyes thorughly with water.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel

Structured Label Content

Use

Antiseptic Spray to help reduce bacteria on the skin.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts

Section 55106-9 (55106-9)

Ethyl Alcohol 75%

Purpose

Antiseptic

Warnings

1.Flammable,Keep away from fire or flame.

2.For external use only.

Directions

Place enough Product in your palm to cover hands and rub hands together briskyly until dry.

Children under 6 years of age should be supervised when using

Other Information (Other information)

Store below 110°F.(43℃)·

May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

ALCOHOL(75%) , AQUA, POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE 0.36%-0.44%

When Using This Product (When using this product)

do not use in or near the eyes. In case of contact,rinse eyes thorughly with water.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "POLIHEXANIDE HYDROCHLORIDE", "unii": "4XI6112496", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Antiseptic Spray to help reduce bacteria on the skin.", "50566-9": "Stop use and ask a doctor if irritation or rash appears and lasts", "55106-9": "Ethyl Alcohol 75%", "Purpose": "Antiseptic", "Warnings": "1.Flammable,Keep away from fire or flame. 2.For external use only.", "Directions": "Place enough Product in your palm to cover hands and rub hands together briskyly until dry. Children under 6 years of age should be supervised when using", "Other information": "Store below 110°F.(43℃)· May discolor certain fabrics or surfaces.", "Inactive ingredients": "ALCOHOL(75%) , AQUA, POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE 0.36%-0.44%", "When using this product": "do not use in or near the eyes. In case of contact,rinse eyes thorughly with water.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:25.607462 · Updated: 2026-03-14T22:56:35.991862