Search by Drug Name or NDC

NDC 81197-0000-05 Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent 1.3 mg/mL Details

Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent 1.3 mg/mL

Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Ironcompany.com, LLC. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	81197-0000
Product ID	81197-000_ba0b750e-42d8-3b64-e053-2a95a90aebe3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Iron Company Heavy Duty Sanitizing Alcohol Free Wipes Fresh Lemon Scent
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Ironcompany.com, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2022-12-31

Package

Package Images

NDC 81197-0000-05 (81197000005)

Pricing Information	N/A
NDC Package Code	81197-000-05
Billing NDC	81197000005
Package	800 PATCH in 1 CANISTER (81197-000-05) / 4.1 mL in 1 PATCH
Marketing Start Date	2020-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b60cb560-b85d-b8b7-e053-2995a90a7d6b Details

DRUG FACTS

ACTIVE INGREDIENTS

Benzalkonium chloride 0.13%

Purpose

Antiseptic

USES

• For hand sanitizing to decrease bacteria on the skin.

• Apply topically to the skin to help prevent cross contamination.

• Recommended for repeated use.

• Dries in seconds.

WARNINGS

• For external use only

• May irritate eyes

Keep out of the reach of children

unless under adult supervision

DIRECTIONS

• Tear V notch on top of plastic bag.

• Pull first wipe from the center of roll up through opening of bag.

• Thread first wipe through the dispensing nozzle in lid of floor stand or dispenser.

• Close dipenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.

INACTIVE INGREDIENTS

Water (Aqua), Propylene Glycol, Polysorbate 20, Disodium Cocoamphodiacetate, Citric Acid, Disodium EDTA, Potassium Sorbate,

Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance.

Package Labeling:

Package Labeling:81197-000-05

INGREDIENTS AND APPEARANCE

IRON COMPANY HEAVY DUTY SANITIZING ALCOHOL FREE WIPES FRESH LEMON SCENT

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81197-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81197-000-08	800 in 1 BAG	12/15/2020
1		4.1 mL in 1 PATCH; Type 0: Not a Combination Product
2	NDC:81197-000-05	800 in 1 CANISTER	12/15/2020
2		4.1 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/15/2020

Labeler - Ironcompany.com, LLC (004628657)

Revised: 1/2021

Document Id: ba0b750e-42d8-3b64-e053-2a95a90aebe3

Set id: b60cb560-b85d-b8b7-e053-2995a90a7d6b

Version: 2

Effective Time: 20210129