G0abhw03

G0abhw03
SPL v1
SPL
SPL Set ID 428be471-6330-46eb-8637-5e8f571373f7
Route
TOPICAL
Published
Effective Date 2020-06-30
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 Eucalyptus Globulus Leaf Water Fd&c Yellow No. 5 Fd&c Blue No. 1 Mentha Arvensis Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-30
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

■ To decrease bacteria on hands

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

Section 51945-4

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, Eucalyptus Globulus Leaf Extract, Mentha Arvensis

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 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

Section 51945-4 (51945-4)

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, Eucalyptus Globulus Leaf Extract, Mentha Arvensis

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: 2026-02-15T11:58:04.519801 · Updated: 2026-03-14T22:57:27.471846