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

1
(click image for full-size original)

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

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