77878-031, Style: Wp0024 Pea

77878-031, Style: Wp0024 Pea
SPL v1
SPL
SPL Set ID 6132f03f-82a7-4df0-8149-292a8d8df842
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 Yellow No. 5 Methylchloroisothiazolinone D&c Red No. 7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-23
Description

Benzalkonium Chloride  0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

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

Warnings

For external use only

Directions
  • Wet hands 
  • Apply palmful to hands
  • Scrub thoroughly for at least 15 seconds
  • Rinse thoroughly and dry
Active Ingredient(s)

Benzalkonium Chloride  0.13%

Inactive Ingredients

Water, Cocamidopropyl dimethylamine oxide, Citric Acid, Fragrance, Kathon, Glycerin, Fatty acyl diethanol amine, Disodium EDTA, Hydroxyethyl Cellulose (250HHR), Red 7 (CI 16255), Yellow 5 (CI 19140)

Structured Label Content

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)

Purpose

Antibacterial

Warnings

For external use only

Directions
  • Wet hands 
  • Apply palmful to hands
  • Scrub thoroughly for at least 15 seconds
  • Rinse thoroughly and dry
Active Ingredient(s)

Benzalkonium Chloride  0.13%

Inactive Ingredients (Inactive ingredients)

Water, Cocamidopropyl dimethylamine oxide, Citric Acid, Fragrance, Kathon, Glycerin, Fatty acyl diethanol amine, Disodium EDTA, Hydroxyethyl Cellulose (250HHR), Red 7 (CI 16255), Yellow 5 (CI 19140)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:11.331270 · Updated: 2026-03-14T22:59:04.734496