Hand Sanitizer by McKenzie Creative Brands, LLC

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by McKenzie Creative Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
McKenzie Creative Brands, 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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Ethyl Alcohol 64% v/v

Antiseptic

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

For external use only. Flammable. Keep away from heat or flame.

in children less than 2 months of age

on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Store between 59-86°F (15-30°C)

Avoid freezing and excessive heat above 104°F (40°C)

Replace cap tightly after use.

Dispense directly from original container. Not for refill purposes.

water, aloe barbadensis leaf juice, isopropyl myristate, glycerin, triethanolamine, carbomer, fragrance

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78200-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	64 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	0.25 g  in 100 mL
LINALYL ACETATE (UNII: 5K47SSQ51G)	0.0008 mL  in 100 mL
CITRONELLA OIL (UNII: QYO8Q067D0)	0.0004 mL  in 100 mL
OCTOXYNOL-8 (UNII: 48RF3T316O)	0.04 mL  in 100 mL
NONOXYNOL-9 (UNII: 48Q180SH9T)	0.024 mL  in 100 mL
COUMARIN (UNII: A4VZ22K1WT)	0.0004 mL  in 100 mL
NEROL (UNII: 38G5P53250)	0.0004 mL  in 100 mL
ORANGE OIL (UNII: AKN3KSD11B)	0.008 mL  in 100 mL
GERANIOL (UNII: L837108USY)	0.0004 mL  in 100 mL
4-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 21EUM2B8UC)	0.0004 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	35.295 mL  in 100 mL
LINALOOL, (+/-)- (UNII: D81QY6I88E)	0.0008 mL  in 100 mL
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)	0.0016 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.125 mL  in 100 mL
LIME OIL (UNII: UZH29XGA8G)	0.0016 mL  in 100 mL
CITRAL (UNII: T7EU0O9VPP)	0.0008 mL  in 100 mL
10-UNDECENAL (UNII: DU1OTA08RY)	0.0004 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.125 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.25 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78200-004-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/02/2021
2	NDC: 78200-004-64	1890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2021
3	NDC: 78200-004-99	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/02/2021	03/03/2023

Labeler - McKenzie Creative Brands, LLC (117526609)

Revised: 3/2022

Document Id: daf8ef5b-79ac-c56b-e053-2995a90a99c3

34390-5

Set id: bc2af2d5-3004-6ddf-e053-2995a90a48ca

Version: 3

Effective Time: 20220324