Arizona Biltmore Hand Sanitizer

Arizona Biltmore Hand Sanitizer by

Drug Labeling and Warnings

Arizona Biltmore Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by A.D.S. Sales Co. Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ARIZONA BILTMORE HAND SANITIZER- alcohol gel 
A.D.S. Sales Co. Inc.

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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Arizona Biltmore Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 72% (v/v)

Purpose

Antibacterial

Uses

To help reduce bacteria on the skin.

Warnings

• For external use only.
• Flammable.
• Keep away from fire or flame. 

When using this product

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if

• Irritation or redness develops and lasts.

Keep out of reach of children

• In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

• Squeeze a significant amount in your palm and rub hands until fully dry.
• Rinse free.

Other information

• Store below 110°F (43°C).

Inactive ingredients

Aqua (Water), Glycerin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Hydrolyzed Jojoba Esters, Phenoxyethanol, Parfum(Fragrance), Aminomethyl Propanol, Tocopherol, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Fruit Extract, Olea Europaea (Olive) Fruit Oil

Package Labeling:

ARIZONA BILTMORE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79249-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.72 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ORANGE (UNII: 5EVU04N5QU)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79249-028-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/30/2020	12/31/2022

Labeler - A.D.S. Sales Co. Inc. (051216828)

Revised: 3/2023

Document Id: f7ab9ac6-fcb2-3dd4-e053-6394a90a6e4c

34390-5

Set id: b62029af-3a78-cc79-e053-2a95a90a7048

Version: 3

Effective Time: 20230324