OTC Medication Information: Uncle Buds Hand Sanitizer

UNCLE BUDS HAND SANITIZER- isopropyl alcohol gel
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

Isopropyl Alcohol 70%

Purpose

Antiseptic

Use

to decrease bacteria on the skin that could cause disease

Warnings

For external use only

Flammable. Keep away from heat or flame.

When using this product

  • Keep out of eyes. In case of eye contact, flush with plenty of water and seek medical advice.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop use and ask a doctor if

  • Irrirtation or redness develops

Keep out of reach of children

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

Directions

Wet palms thoroughly with product and rub hands together until dry. 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

C12-15 Alkyl Benzoate, Carbomer, Glycerin, Sodium Hydroxide, Water

Questions?

Visit Unclebudshemp.com

Bottle Label

Bottle Label
(click image for full-size original)

UNCLE BUDS HAND SANITIZER
isopropyl alcohol gel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72680-008
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
ALKYL (C12-15) BENZOATE
SODIUM HYDROXIDE
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72680-008-01 227 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 (72680-008), analysis (72680-008)

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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