SANITIZING HAND WIPES- benzalkonium chloride cloth

Sanitizing Hand wipes by

Drug Labeling and Warnings

Sanitizing Hand wipes by is a Otc medication manufactured, distributed, or labeled by Landy International, Zhangzhou Kingbaby Health products Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antiseptic/Hand & Skin Sanitizer

Use

Sanitizing Hand Wipes to help decrease bacteria on the skin.
Recommended for single use.

Warnings

Do not freeze. For external use only.
Do not use in ears, eyes or mouth.
●Avoid contact with the eyes. In case of contact, flush eyes with water.
●Stop use and ask a doctor if redness or iritation
develop and persist for more than 72 hours.
●Keep out of reach of children.
●Children should be supervised when using this product.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Wipe liberally over the hands & body, rub into skin until dry.
Recommended for single use.

Inactive ingredients

Aloe Barbadensis leaf extract, Aqua, Citric Acid, CaprylyI Glucoside,
Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl
Steardimonium Chloride.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SANITIZING HAND WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51706-907
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXY(3-ISOCYANATOPROPYL)SILANE (UNII: 9BR6002P6E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
LAURETH-4 (UNII: 6HQ855798J)
POLIHEXANIDE (UNII: 322U039GMF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIMETHYL OCTADECYL AMMONIUM CHLORIDE (UNII: CZ70647U92)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51706-907-01	650 g in 1 TUBE; Type 0: Not a Combination Product	05/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/27/2020

Labeler - Landy International (545291775)

Establishment
Name	Address	ID/FEI	Business Operations
Zhangzhou Kingbaby Health products Co.,Ltd		415797593	manufacture(51706-907)