G0abhw01

G0abhw01
SPL v1
SPL
SPL Set ID fc4a15a0-70fc-4831-8902-8b570b0fadea
Route
TOPICAL
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Cocamidopropyl Betaine Dmdm Hydantoin Disodium Hedta Citric Acid Monohydrate Melaleuca Alternifolia Whole Water Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-29
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

■ To decrease bacteria on hands

Section 42229-5
Section 50566-9

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

Warnings

For external use only

Directions

Pump soap into dry hands. Lather for at least 20 seconds and rinse thoroughly

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Melaleuca Alternifolia (Tea Tree) Extract, Yellow 5, Blue 1

Keep Out of Reach of Children

Keep out of reach of children

Structured Label Content

Use

■ To decrease bacteria on hands

Section 42229-5 (42229-5)
Section 50566-9 (50566-9)

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

Purpose

Antibacterial

Warnings (WARNINGS)

For external use only

Directions

Pump soap into dry hands. Lather for at least 20 seconds and rinse thoroughly

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Melaleuca Alternifolia (Tea Tree) Extract, Yellow 5, Blue 1

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

Keep out of reach of children

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:05.539229 · Updated: 2026-03-14T22:57:28.915858