OTC Medication Information: Uncle Buds Hand Sanitizer with Hemp Oil

UNCLE BUDS HAND SANITIZER WITH HEMP OIL- benzalkonium chloride liquid
CBH International LLC

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

Benzalkonium Chloride 0.1% w/w

Purpose

Antiseptic

Use

to decrease bacteria on the skin that coulc cause disease. Recommended for repeated use

Warnings

For external use only.

When using this product

• Keep out of eyes. In case of eye contact, flush with plenty of water and seek medical advice.

Stop use and ask a doctor if

• irritation or redness develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands throroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

Other Information

Store at room temperature. Avoid excessive heat.

Inactive Ingredients

Aloe Vera Leaf, Caesalpinia Spinosa Gum, Cannabis Sativa Seed Oil, Canola Oil, Diethylene Glycol Mononethyl Ether, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Safflower Oil, Water

Questions?

Visit UInclebudshemp.com

Bottle Label

UNCLE BUDS HAND SANITIZER WITH HEMP OIL benzalkonium chloride liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72680-011 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 mg in 1 mL

Inactive Ingredients Ingredient Name Strength DIETHYLENE GLYCOL MONOETHYL ETHER WATER SAFFLOWER OIL CANNABIS SATIVA SEED OIL CANOLA OIL GLYCERIN ETHYLHEXYLGLYCERIN PHENOXYETHANOL ALOE VERA LEAF CAESALPINIA SPINOSA RESIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72680-011-01 227 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/31/2020

Labeler — CBH International LLC (116834275)

Establishment
Name	Address	ID/FEI	Operations
TAKA USA Inc. dba Cosmetic Innovations		802860515	manufacture (72680-011), analysis (72680-011)

Revised: 01/2021 CBH International LLC