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

Bottle Label
(click image for full-size original)

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

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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