HACCP Flat Top E-2: Package Insert and Label Information

HACCP FLAT TOP E-2- chloroxylenol liquid
Best Sanitizers Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

510-001-012-802

Manufactured For and Distributed By:
BEST SANITIZERS, INC.
P.O. BOX 1360
17320 PENN VALLEY DRIVE
PENN VALLEY, CA 95946
PHONE: 530-432-7460
TOLL FREE: 888-225-3267
PHONE: 530-432-0752

Principal Display Panel – Bottle Label

Bottle Label:

BEST SANITIZERS, INC.

HACCP

Flat Top E-2 Lotion Soap

An Anti-Microbial Lotion Hand Wash
Formulated To Clean Effectively, Yet Gently

CAUTION Keep Out Of Reach Of Children

See back panel for additional precautionary information.

Principal Display Panel – Bottle Label
(click image for full-size original)
HACCP FLAT TOP E-2
chloroxylenol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59900-510
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
chloroxylenol (chloroxylenol) chloroxylenol 15.75 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
water
sodium laureth sulfate
cocamidopropyl betaine
hydroxyethyl cellulose (2000 CPS at 1%)
isopropyl alcohol
coco diethanolamide
triclosan
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59900-510-55 3785 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/28/1998
Labeler — Best Sanitizers Inc. (957473614)
Establishment
Name Address ID/FEI Operations
Canberra Corporation 068080621 MANUFACTURE

Revised: 09/2010 Best Sanitizers Inc.

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