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NDC 51706-0958-01 HAND SANITIZE WIPES 0.13 g/100g Details

HAND SANITIZE WIPES 0.13 g/100g

HAND SANITIZE 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	51706-0958
Product ID	51706-958_dab5f0d4-1cb7-6052-e053-2995a90a3076
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	HAND SANITIZE 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 51706-0958-01 (51706095801)

Pricing Information	N/A
NDC Package Code	51706-958-01
Billing NDC	51706095801
Package	50 NOT APPLICABLE in 1 BAG (51706-958-01) / .0048 g in 1 NOT APPLICABLE
Marketing Start Date	2020-10-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b3160e59-b689-0c2e-e053-2a95a90ab99c Details

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

Uses santizing hand wipes to help decrease bacteria on the skin.recommended for single use.

Warnings

For external use only

Do not use if you are allergic to any of the ingredients.

When using this product do not get into eyes. If contact occurs, flush eyes in water.

stop use and ask a doctor if irritation develops and condition for more than 72 hours.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. Children should be supervised when using this product.

Directions

Directions wipe liberally over the hands & body, rub into skin until

Other information

Other information Do not store above 110°F(43℃).

Inactive ingredients

aloe extract, glycerin, phenoxyethanol, purified water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZE WIPES

benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-958
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-958-01	50 in 1 BAG	10/30/2020
1		0.0048 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	10/30/2020

Labeler - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Fujian Yifa Healthcare Products Co.,Ltd.		420510793	manufacture(51706-958)

Revised: 3/2022

Document Id: dab5f0d4-1cb7-6052-e053-2995a90a3076

Set id: b3160e59-b689-0c2e-e053-2a95a90ab99c

Version: 2

Effective Time: 20220321