SPL v3
SPL
SPL Set ID 02859771-7269-c22e-e063-6294a90a56ed
Route
TOPICAL
Published
Effective Date 2023-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.3 g)
Inactive Ingredients
Dmdm Hydantoin Lauramine Oxide Sodium Hydroxide Anhydrous Citric Acid Sodium Chloride Dodecylbenzenesulfonic Acid Water Urea Sodium C12-14 Alketh-3 Sulfate Alcohol Cocamidopropyl Betaine Sodium Xylenesulfonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-08-09 Until 2026-07-01

Description

Drug Facts

Purpose

Antibacterial hand soap


Medication Information

Purpose

Antibacterial hand soap

Description

Drug Facts

Use

For handwashing to decrease bacteria on the skin

Section 42229-5

Drug Facts

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

Compare to

Dawn ® Ultra Green Apple

Simplify ®

Antimicrobial

Hand Soap & Ultra Dish

Detergent

  • Contains no

phosphates

  • Cuts Grease

APPLE

BLOSSOM

SCENT

19.4 FL OZ (1.21 PT) 573 mL

Warnings

For external use only

Directions
  • Wet hands.
  • Apply palmful to hands.
  • Scrub thoroughly and rinse with water.
Active Ingredient

Chloroxylenol 0.30%

Inactive Ingredients

Carbamide, citric acid, cocamidopropyl betaine, DMDM hydroton, dodecylbenzene sulfonic acid, ethyl alcohol, fragrance, lauramine oxide, sodium chloride, sodium hydroxide, sodium lauryl ether sulfate, sodium xylene sulfonate, water


Structured Label Content

Use

For handwashing to decrease bacteria on the skin

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Compare to

Dawn ® Ultra Green Apple

Simplify ®

Antimicrobial

Hand Soap & Ultra Dish

Detergent

  • Contains no

phosphates

  • Cuts Grease

APPLE

BLOSSOM

SCENT

19.4 FL OZ (1.21 PT) 573 mL

Purpose

Antibacterial hand soap

Warnings

For external use only

Directions
  • Wet hands.
  • Apply palmful to hands.
  • Scrub thoroughly and rinse with water.
Active Ingredient

Chloroxylenol 0.30%

Inactive Ingredients

Carbamide, citric acid, cocamidopropyl betaine, DMDM hydroton, dodecylbenzene sulfonic acid, ethyl alcohol, fragrance, lauramine oxide, sodium chloride, sodium hydroxide, sodium lauryl ether sulfate, sodium xylene sulfonate, water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)