77878-028, style: wp0024 cuc

77878-028, style: wp0024 cuc
SPL v1
SPL
SPL Set ID b193e564-168b-4964-9f42-35191ac9b493
Route
topical
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
water citric acid monohydrate glycerin disodium hedta hydroxyethyl cellulose, unspecified fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-12-23
Purpose

Antibacterial

Description

Benzalkonium Chloride  0.13%

Medication Information

Warnings

For external use only

Purpose

Antibacterial

Directions
  • Wet hands 
  • Apply palmful to hands
  • Scrub thoroughly for at least 15 seconds
  • Rinse thoroughly and dry
Inactive Ingredients

Water, Cocamidopropyl dimethylamine oxide, Citric Acid, Fragrance, Kathon, Glycerin, Fatty acyl diethanol amine, Disodium EDTA, Hydroxyethyl Cellulose (250HHR), CI 51436, Blue 1 (CI 42090)

Description

Benzalkonium Chloride  0.13%

Use

For hand washing to decrease bacteria on the skin

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 and redness develop, condition persists for more than 72 hours

Section 50567-7

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Section 51945-4

Active Ingredient(s)

Benzalkonium Chloride  0.13%

Structured Label Content

Warnings

For external use only

Purpose

Antibacterial

Directions
  • Wet hands 
  • Apply palmful to hands
  • Scrub thoroughly for at least 15 seconds
  • Rinse thoroughly and dry
Inactive Ingredients (Inactive ingredients)

Water, Cocamidopropyl dimethylamine oxide, Citric Acid, Fragrance, Kathon, Glycerin, Fatty acyl diethanol amine, Disodium EDTA, Hydroxyethyl Cellulose (250HHR), CI 51436, Blue 1 (CI 42090)

Use

For hand washing to decrease bacteria on the skin

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 and redness develop, condition persists for more than 72 hours

Section 50567-7 (50567-7)

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Section 51945-4 (51945-4)

Active Ingredient(s)

Benzalkonium Chloride  0.13%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:11.351147 · Updated: 2026-03-14T22:59:04.734496