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NDC 51706-0954-01 Crazy Cleanz Hand Sanitizer Eucalyptus Scented 0.1 g/100g Details

Crazy Cleanz Hand Sanitizer Eucalyptus Scented 0.1 g/100g

Crazy Cleanz Hand Sanitizer Eucalyptus Scented is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Landy International. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	51706-0954
Product ID	51706-954_dab5c2ee-9b01-5658-e053-2a95a90afeb8
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	Crazy Cleanz Hand Sanitizer Eucalyptus Scented
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.1
Active Ingredient Units	g/100g
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Landy International
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51706-0954-01 (51706095401)

Pricing Information	N/A
NDC Package Code	51706-954-01
Billing NDC	51706095401
Package	50 g in 1 BOTTLE (51706-954-01)
Marketing Start Date	2020-09-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL af63761c-b5a8-1d52-e053-2995a90ab14e Details

Active Ingredient(s)

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Use

helps eliminate bacteria on hands

Warnings

For external use only

Do not use

. In children less than 2 months of age. On open skin wounds

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thouroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

These may be a sign of a serious condition.

SPL UNCLASSIFIED SECTION

Keep out of reach of children, except under adult supervision.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

-Place enough product on hands to cover all surfaces.

· Rub hands together until dry.

.Supervise children under 6 years of age when using this product

to avoid swallowing.

Inactive ingredients

Blue 1(Cl 42090), Didecyldimonium chloride,Fragrance(Parfum),Glycerin,

PEG-40 hydrogenated castor oil, Polyaminopropyl biguanide,

Water(Aqua),Yellow 5(C119140).

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

CRAZY CLEANZ HAND SANITIZER EUCALYPTUS SCENTED

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-954
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51706-954-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/15/2020

Labeler - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(51706-954)

Revised: 3/2022

Document Id: dab5c2ee-9b01-5658-e053-2a95a90afeb8

Set id: af63761c-b5a8-1d52-e053-2995a90ab14e

Version: 2

Effective Time: 20220321