Sanitizing Hand Wipes: Package Insert and Label Information

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.

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:51706-907 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 g

Inactive Ingredients Ingredient Name Strength TRIETHOXY(3-ISOCYANATOPROPYL)SILANE PHENOXYETHANOL CITRIC ACID MONOHYDRATE WATER CAPRYLYL GLUCOSIDE LAURETH-4 POLIHEXANIDE ALOE VERA LEAF TRIMETHYL OCTADECYL AMMONIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51706-907-01 650 g in 1 TUBE None

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	Operations
Zhangzhou Kingbaby Health products Co.,Ltd		415797593	manufacture (51706-907)

Revised: 05/2020 Landy International