77878-018/wp0008, Wp0008m

SPL v1

SPL

SPL Set ID 24d1e602-083d-4bbd-bcc9-101ed96246ea

Route

TOPICAL

Published

Effective Date 2020-11-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Water Phenoxyethanol Glycerin .alpha.-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-11-07

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

■ To decrease bacteria on the skin that could cause disease

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Section 51945-4

Warnings

For external use only. Flammable.

When using this product,

keep out of eyes. In case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Directions

Hold can upright 6"-8" from hand.

Spray 3-4 seconds until covered with mist

For children under 6, use only under adult supervision

Not recommended for infants

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Contents under pressure

Keep away from heat, sparkles, and open flame

Do not puncture or incinerate container

keep in dry, cool and well ventilated place

Recommended storage temperature: 32F-104F (0-40C)

Inactive Ingredients

Aloe Barbadensis Leaf Etract, Fragrance, Glycerin, Phenoxyethanol, Tocopheryl Acetate, Water

Structured Label Content

Use

■ To decrease bacteria on the skin that could cause disease

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings (WARNINGS)

For external use only. Flammable.

When using this product,

keep out of eyes. In case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Directions

Hold can upright 6"-8" from hand.

Spray 3-4 seconds until covered with mist

For children under 6, use only under adult supervision

Not recommended for infants

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Contents under pressure

Keep away from heat, sparkles, and open flame

Do not puncture or incinerate container

keep in dry, cool and well ventilated place

Recommended storage temperature: 32F-104F (0-40C)

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Etract, Fragrance, Glycerin, Phenoxyethanol, Tocopheryl Acetate, Water

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "■ To decrease bacteria on the skin that could cause disease", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition", "Purpose": "Antibacterial", "WARNINGS": "For external use only. Flammable. When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water Avoid contact with broken skin", "Directions": "Hold can upright 6"-8" from hand. Spray 3-4 seconds until covered with mist For children under 6, use only under adult supervision Not recommended for infants", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Other Information": "Contents under pressure Keep away from heat, sparkles, and open flame Do not puncture or incinerate container keep in dry, cool and well ventilated place Recommended storage temperature: 32F-104F (0-40C)", "Inactive ingredients": "Aloe Barbadensis Leaf Etract, Fragrance, Glycerin, Phenoxyethanol, Tocopheryl Acetate, Water"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:00.520165 · Updated: 2026-03-14T22:58:50.271611