Koala Hand Sanitizer - Peppermint

Koala Hand Sanitizer Peppermint by

Drug Labeling and Warnings

Koala Hand Sanitizer Peppermint by is a Otc medication manufactured, distributed, or labeled by Beaming White LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KOALA HAND SANITIZER PEPPERMINT- alcohol gel 
Beaming White 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.

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Koala Hand Sanitizer - Peppermint

Active Ingredient(s)

Ethyl Alcohol 68% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to reduce bacterial organisms on the skin.

Warnings

Flammable. Keep away from fire or flame

Do not use

For external use only.

Avoid contact with eyes. If contact occurs, flush eyes thoroughly with water.



Stop use and ask a doctor if irritation or rash occurs.



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Dispense a small amount onto palm of hand and rub briskly and thoroughly over surfaces of both hands until dry.
• Children under 6 years of age should be supervised while using this product.

Other information

• Store below 110 °F (43 °C)
• May discolor certain fabrics or surfaces.

Stop use and ask a doctor if irritation or rash develops and persists.

Inactive ingredients

Water, Glycerin, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Mentha Piperita (Peppermint Oil), Triethanolamine

Package Label - Principal Display Panel

KOALA HAND SANITIZER PEPPERMINT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75669-0201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)	0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)	0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.65 mL  in 100 mL
PEPPERMINT OIL (UNII: AV092KU4JH)	2 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75669-0201-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2020
2	NDC: 75669-0201-6	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/17/2020	03/31/2022

Labeler - Beaming White LLC (019910700)

Registrant - Beaming White LLC (019910700)

Establishment
Name	Address	ID/FEI	Business Operations
Beaming White LLC		019910700	manufacture(75669-0201) , label(75669-0201)

Revised: 1/2022

Document Id: d6ad648e-22a9-49d9-e053-2a95a90a66cb

34390-5

Set id: abc7b21e-7704-0b6b-e053-2a95a90aaf51

Version: 2

Effective Time: 20220128