High Five Antibacterial Hand by Janisource, LLC

Drug Details [pdf]

HIGH FIVE ANTIBACTERIAL HAND- chloroxylenol soap
Janisource, LLC

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Active Ingredient

Chloroxylenol 0.1%

Purpose

Antiseptic

Uses

Handwash to help decrease bacteria on the skin.

Warnings

For external use only.
Do not use in the eyes. In case of contact, immediately flush eyes with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly.
Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water (Aqua) (7732-18-5), Sodium C14-16 Olefin Sulfonate (68439-57-6), Cocamidopropyl Hydroxysultaine (68139-30-0), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Propylene Glycol (57-55-6), Sodium Polyitaconate (26099-89-8), Fragrance (Proprietary), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), Dibromocyanoacetamide (10222-01-2), Yellow 5 (1934-21-0), Red 40 (25956-17-6).

Principal Display Panel

HIGH FIVE ANTIBACTERIAL HAND
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49557-701
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	1 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EUGENOL (UNII: 3T8H1794QW)
CINNAMALDEHYDE (UNII: SR60A3XG0F)
WATER (UNII: 059QF0KO0R)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BRONOPOL (UNII: 6PU1E16C9W)
SODIUM POLYITACONATE (2800 MW, PHOSPHATE TERMINATED) (UNII: G7SW5QN7TT)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
DIBROMOCYANOACETAMIDE (UNII: 7N51QGL6MJ)

Product Characteristics
Color	orange (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49557-701-41	3.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	03/08/2023	01/16/2026

Labeler - Janisource, LLC (079224675)

Revised: 6/2025

Document Id: 380486f9-ae52-95de-e063-6294a90a091c

Set id: f665a352-775d-ebcc-e053-2a95a90ae362

Version: 4

Effective Time: 20250620