OPI ANTISEPTIC FOAMING HAND CLEANER- chloroxylenol liquid

OPI Antiseptic Foaming Hand Cleaner by

Drug Labeling and Warnings

OPI Antiseptic Foaming Hand Cleaner by is a Otc medication manufactured, distributed, or labeled by OPI Correctional Industries, Canberra Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient:

Chloroxylenol (1.49% w/w)

Purpose:

Anti-Microbial Hand Cleanser

Uses

• Helps reduce bacteria that potentially can cause disease
• Helps prevent cross contamination by hand contact

Warnings

• For external use only

• Keep out of reach of children.
• In case of eye contact flush with water for 15 minutes, if irritation persists, get medical attention.
• In case of accidental ingestion, seek medical attention or contact a poison control center immediately.
• This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
• Do not contaminate water, food or feed by storage and disposal.

Directions

• Apply cleaner to palm of hand
• Lather and scrub hands (including fingers, wrist, and cuticles) vigorously for 60 seconds
• Rinse with water until all cleaner is removed from hands
• Dry completely (incomplete drying may lead to chapped skin).

Inactive Ingredients

Water, 2-Propanol, Sodium Laureth Sulfate, Cocoamidopropyl Betaine, Cocoamphoproprionate,

Cocoamide, Hydroxyethyl Cellulose, Triclosan

Principal Display Panel

Bottle Label:

OPI

PERSONAL CARE SUPPLIES

ANTISEPTIC FOAMING HAND CLEANER

An Anti-Microbial Lotion Hand

Wash Formulated To Clean

Effectively, Yet Gently.

See side panel for additional information.

INGREDIENTS AND APPEARANCE

OPI ANTISEPTIC FOAMING HAND CLEANER 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43196-510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q)	chloroxylenol	15.75 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium laureth sulfate (UNII: BPV390UAP0)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
hydroxyethyl cellulose (2000 CPS at 1%) (UNII: S38J6RZN16)
isopropyl alcohol (UNII: ND2M416302)
coco diethanolamide (UNII: 92005F972D)
triclosan (UNII: 4NM5039Y5X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43196-510-05	3785 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/07/2011

Labeler - OPI Correctional Industries (809174501)

Establishment
Name	Address	ID/FEI	Business Operations
Canberra Corporation		068080621	MANUFACTURE