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NDC 51706-0955-01 Crazy Cleanz Hand Wipes 0.13 g/100g Details

Crazy Cleanz Hand Wipes 0.13 g/100g

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

Product Information

NDC	51706-0955
Product ID	51706-955_dab62819-68e5-783d-e053-2995a90a09d8
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 Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	0.13
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	2023-12-31

Package

Package Images

NDC 51706-0955-01 (51706095501)

Pricing Information	N/A
NDC Package Code	51706-955-01
Billing NDC	51706095501
Package	20 NOT APPLICABLE in 1 BAG (51706-955-01) / .00429 g in 1 NOT APPLICABLE
Marketing Start Date	2020-09-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL af63d8f9-3b5b-788e-e053-2a95a90a981d Details

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

helps eliminate bacteria on hands

Warnings

For external use only

Do not use

●On 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

Open resealable label and take out one wipe at a time. After use 0n

surface, dispose of wipe in trash receptable. Do not flush down toilet.

When finished, reseal pouch to preserve moisture.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Fragrance (Parfum), Glycerin, Phenoxyethanol, Water(Aqua).

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

CRAZY CLEANZ HAND WIPES

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-955
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-955-01	20 in 1 BAG	09/15/2020
1		0.00429 g in 1 NOT APPLICABLE; 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	part333A	09/15/2020

Labeler - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Landy International		545291775	manufacture(51706-955)

Revised: 3/2022

Document Id: dab62819-68e5-783d-e053-2995a90a09d8

Set id: af63d8f9-3b5b-788e-e053-2a95a90a981d

Version: 2

Effective Time: 20220321