SANITIZING HAND WIPES- benzalkonium chloride cloth
Landy International

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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51706-905 Sanitizing wipes 0.13% Benzalkonium Chloride

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.

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

SANITIZING HAND WIPES
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51706-905
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
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51706-905-01	650 g in 1 TUBE; Type 0: Not a Combination Product	05/27/2020
2	NDC:51706-905-02	120 g in 1 BAG; Type 0: Not a Combination Product	05/27/2020

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

Labeler - Landy International (545291775)

Name	Address	ID/FEI	Business Operations
Establishment
Zhangzhou Kingbaby Health products Co.,Ltd		415797593	manufacture(51706-905)