AFCO 5515 HAND SANITIZER- isopropyl alcohol lotion

AFCO 5515 Hand Sanitizer by

Drug Labeling and Warnings

AFCO 5515 Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Acuity Specialty Products, Inc dba AFCO US. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active Ingredients: lsopropyl Alcohol 75%

PURPOSE

Purpose: Antiseptic

INDICATIONS & USAGE

Uses Helps prevent cross contamination by hand contact Helps prevent drying and chafing of skin Recommended for repeat use

WARNINGS

Warnings
For external use only

OTHER SAFETY INFORMATION

Flammable, keep away from fire or flame.

WHEN USING

​When using this product do not use in or near eyes. Discontinue use if irritation or redness develops. Use in well-ventilted area.

STOP USE

Stop use and ask a doctor if irritation persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact poison control center immediately.

DOSAGE & ADMINISTRATION

Directions:

Place a palmful of product in one hand Spread on both hands and rub into the skin until dry (1-2 min.) No rinsing or toweling required

OTHER SAFETY INFORMATION

Other Information:

Store in a cool dry place below 104°F Recommended for use in AFCO Systems For Food Processing, Food Service and Professional Use Only

INACTIVE INGREDIENT

Inactive Ingredients:

Water, glycerin

QUESTIONS

Questions or Comments:

For product or technical information, contact AFCO Monday to Friday 8 AM to 4 PM EST at 1-800-345-1329 or visit our website at www.afcocare.com

Product Package

AFCO 5515

Hand Sanitizer

MANUFACTURED BY:
Alex C. Fergusson, LLC
800 DEVELOPMENT AVENUE
CHAMBERSBURG, PA 17201
TOLL FREE: 800-345-1329

NDC# 68776-1007-5
BATCH NO.:
EXP. DATE: 00/00/2000
CONTENTS: 2L (68 fl. oz.)

CHEMTREC EMERGENCY 800-424-9300

(Chemtrec Customer Number: CCN837)

HMIS HAZARD RATING
HEALTH                                 1

FLAMMABILITY                  3

REACTIVITY                        0

PERSONAL PROTECTION A

CHEMTREC EMERGENCY 800-424-9300

(Chemtrec Customer Number: CCN837)

2-Liter Bag Label

2 x 2L Case Label

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INGREDIENTS AND APPEARANCE

AFCO 5515 HAND SANITIZER 
isopropyl alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68776-1007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7575 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68776-1007-5	2 in 1 BOX	03/16/2020
1		2000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/16/2020

Labeler - Alex C. Fergusson, Inc. (604091413)

Registrant - Alex C. Fergusson, Inc. (604091413)

Establishment
Name	Address	ID/FEI	Business Operations
Alex C. Fergusson, Inc.		798583154	manufacture(68776-1007) , label(68776-1007)