STOOL COLLECTION KIT FOR GI MOLECULAR TEST- kit

Stool collection kit for GI molecular test by

Drug Labeling and Warnings

Stool collection kit for GI molecular test by is a Other medication manufactured, distributed, or labeled by H&M MEDICAL COLLECTION KITS LLC, GOJO Industries, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KIT Includes

• Lab Tissue Mailer, Overall Height 3-7/8 In., Overall Length 4-1/8 In., Zoro Number: G3670484, Mfr Number: 729/CP; Qty-1
• "Mini Ice Pack from an Ice pack Sqaure Mat, Length 16-1/2 In., Width 14-3/4 In., Height 14-3/4 In., Zoro #: G5830133 | Mfr #: 405SQ ( each matt has 60 pieces, which only one small piece is used)
• Mailing Carton, Capacity 72 cu. in., Color White, Inside Width 4 In., Inside Length 6 In., Inside Depth 3 In,Zoro#: G1072556 | Mfr#: 0101-1681010; Qty-1
• One 3ml transfer pipette; Transfer Pipet, 3.0mL, Small Bulb, Graduated to 1mL, 140mm, Bulb Draw - 2.2mL, globe scientific, item#137035; Qty-1
• One pair of medium latex free gloves
• Bag, Biohazard Specimen Transport, 6" x 9", Ziplock with Document Pouch, Globe scientific,item#4919; Qty-1
• Container, Fecal, 30mL, attached Screw Cap with Spoon, PP, Conical Bottom, Self-Standing, globe scientific, item#109120; Qty-1
• Sterile cotton tipped applicators, Dynarexcorporation, 2 X 6"inch, reorder no. 4305, lot: 25519; Qty-1
• Microtube, 1.5mL, Self-Standing, Attached Screw Cap for Color Insert, with O-Ring, STERILE, PP, globe scientific, item#111720; Qty-2
• Alcohol pads: PT# 5110 PT# # 5110- Prep Surgical Alcohol Pads Webcol Large by, Kendall Company Qty: 2 in each kit
• 1A Mini zip lock with a toilet cover seat: The Hospeco Health Gards half-fold toilet seat cover (part number:HG-1000) which is located inside a mini zip lock. Qty:1
• PURELL Sanitizing Hand Wipes Individually Wrapped: Qty;1 in each kit
• Labels for patient identification
• Instruction sheet for collection the sample
• Requisition form for the clinicians

Drug Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antimicrobial

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Use Hand sanitizer to help reduce bacteria on the skin

WARNINGS

Warnings

Flammable. Keep away from fire or flame,

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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

DOSAGE & ADMINISTRATION

Directions Unfold towelette; Wipe hands; Discard after use

Other information

• Do not store above 110°F (43°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Acetamidopropyl Trimonium Chloride, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Glycerin, Isopropyl Myristate, Propylene Glycol, Retinyl Palmitate, Tocopheryl Acetate, Zea Mays (Corn) Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Methylparaben

Questions?

1-800-321-9647

SPL UNCLASSIFIED SECTION

PACKAGE INFORMATION

NDC: 21749-363-76

Purell Brand®

SANITIZING
HAND WIPE

Kills 99.9% of most common germs
that may make you sick
Not for retail sale

ONE WIPE

Distributed by: GOJO Industries, Inc. Akron OH 44309
Purell is a trademark of Warner-Lambert Company LLC

Packaging

INGREDIENTS AND APPEARANCE

STOOL COLLECTION KIT FOR GI MOLECULAR TEST 
container, specimen, non-sterile kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:70049-211

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:70049-211-70	1 in 1 KIT; Type 1: Convenience Kit of Co-Package

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 APPLICATOR	1.75 mL

Part 1 of 1

PURELL SANITIZING HAND WIPES 
ethyl alcohol cloth

Product Information
Item Code (Source)	NDC: 21749-363
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN OIL (UNII: 8470G57WFM)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21749-363-76	1 in 1 PACKET
1		1.75 mL in 1 APPLICATOR; 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	part333A	01/22/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	NNI	09/01/2015

Labeler - H&M MEDICAL COLLECTION KITS LLC (079931322)

Establishment
Name	Address	ID/FEI	Business Operations
H&M MEDICAL COLLECTION KITS LLC		079931322	repack

Establishment
Name	Address	ID/FEI	Business Operations
GOJO Industries, Inc		036424534	manufacture