OTC Medication Information: Antibacterial Hand Wipes

ANTIBACTERIAL HAND WIPES- quaternium-18 hectorite and benzalkonium chloride cloth
Kunming Ansheng Industry & Trade Co., Ltd.

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)

Quaternary ammonium salt (DDAC) 0.2%v/v;
Benzalkonium Chloride 0.1% v/v.

Purpose

Antibacterial;

Use

For adult: Apply wipe to hands. Allow to air dry without wiping.

Warnings

Warning: Avoid contact with eyes or clothing.

If swallowed, get medical help or contact a poison control center right away.

Do not flush.

Do not use

Children 2 and under: Ask a doctor before use.

Avoid contact with eyes.

For baby items and surfaces that may have contact with food, Please clean with water after applying wipes.

If irritation occurs, Stop use and consult a doctor.

Keep out of reach of children.

Directions

To open: Unscrew lid, remove wipe pouch and dispose of safety sealed bag.

Return wipes, feed centre wipe through dispenser hole.

Secure lid.

Inactive ingredients

Pure water 99.5%; Glycerol 0.1%; Ethylhexyl glycerin 0.1%.

storage and handling

Store in a cool dry place away from direct sunlight.

Package Label — Principal Display Panel

100 wipes in 1 Canister;
NDC: 78183-030-01;

ANTIBACTERIAL HAND WIPES loveit wipes (0.2% ddac) cloth

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78183-030 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUATERNIUM-18 HECTORITE (QUATERNIUM-18 HECTORITE) QUATERNIUM-18 HECTORITE 0.2 U in 100 U BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.1 U in 100 U

Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN 0.1 U in 100 U WATER GLYCERIN 0.1 U in 100 U

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78183-030-01 100 U in 1 CANISTER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/17/2020

Labeler — Kunming Ansheng Industry & Trade Co., Ltd. (421081801)

Establishment
Name	Address	ID/FEI	Operations
Kunming Ansheng Industry & Trade Co., Ltd.		421081801	manufacture (78183-030), label (78183-030)

Revised: 08/2020 Kunming Ansheng Industry & Trade Co., Ltd.