XOXO HAND DISINFECTANT WIPES: Package Insert and Label Information

XOXO HAND DISINFECTANT WIPES- hydrogen cation cloth
Hand Sanitizer LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active Ingredient

Hydrogen Cation .77%

Purpose

Antiseptic

Uses

For hand sanitizing to decrease bacteria on the surface of the skin.

Warnings

For external use only. Do not use if you are allergic to any of the ingredients. Stop using if a rash develops and ask a doctor right away.

Keep Out of Reach of Children

Keep Out of Reach of Children

Directions

Remove top of canister and pull off lid. Thread wipe through the dispenser lid and tear at perforated line in wipe. To maintain moisture, securely close lid and flap.

Other Safety Information

Store under 110º F (43º C)

Inactive Ingredient

Water, Urea

XOXO HAND DISINFECTANT WIPES

XOXO HAND DISINFECTANT WIPES hy-iq water cloth

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76701-402 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN CATION (HYDROGEN CATION) HYDROGEN CATION 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER 940 mg in 1 mL UREA 50 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76701-402-30 59.147 mL in 1 CANISTER None 2 NDC:76701-402-60 118.294 mL in 1 CANISTER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/11/2021

Labeler — Hand Sanitizer LLC (117473019)

Registrant — Hand Sanitizer LLC (117473019)

Establishment
Name	Address	ID/FEI	Operations
Hand Sanitizer LLC		117473019	manufacture (76701-402), label (76701-402), pack (76701-402)

Revised: 09/2021 Hand Sanitizer LLC