XOXO Disinfectant: Package Insert and Label Information

XOXO DISINFECTANT- hydrogen cation spray
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 spraying on hands or hard surfaces in order to help prevent the spreading of germs and bacteria.

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

Spray enough XOXO Skin Disinfectant Spray to thoroughly dampen hands or hard surfaces. For hands, rub together until dry. For surfaces, wipe dry with a clean cloth, towel, or sponge.

Other Safety Information

Store under 110º F (43º C)

Inactive Ingredient

Water, Urea

XOXO DISINFECTANT SPRAY

XOXOSkin Label 8.375x3.5 091021 16 ounce-01
(click image for full-size original)

XOXO DISINFECTANT
hy-iq spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76701-401
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
UREA 50 mg in 1 mL
WATER 940 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76701-401-32 946.353 mL in 1 BOTTLE, SPRAY None
2 NDC:76701-401-16 473.176 mL in 1 BOTTLE, SPRAY None
3 NDC:76701-401-08 237 mL in 1 BOTTLE, SPRAY None
4 NDC:76701-401-02 50.275 mL in 1 BOTTLE, SPRAY 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 (76701-401), label (76701-401), pack (76701-401)

Revised: 09/2021 Hand Sanitizer LLC

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