INSTANT HAND SANITIZER UNSCENTED- alcohol gel

Instant Hand Sanitizer Unscented by

Drug Labeling and Warnings

Instant Hand Sanitizer Unscented by is a Otc medication manufactured, distributed, or labeled by Hydrox Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to help reduce bacteria on the skin that could cause disease

Warnings

Flammable. Keep away from fire or flame

For external use only - hands.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a physician if skin irritation or rash develops.

Keep out of reach of children. If accidently ingested, seek medical help or contact a Poison Control Center immediately.

Directions

• place enough product in your palm to thoroughly cover your hands
• rub hands together briskly until dry
• children under 6 years of age should be supervised when using this product

Other Information

• store at normal room temperature
• may discolor certain fabrics
• may be harmful to wood finishes and plastics

Inactive ingredients

carbomer, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, purified water, tocopheryl acetate, aloe vera gel, AMP-95

SPL UNCLASSIFIED SECTION

MFG BY: HYDROX LABORATORIES
825 Tollgate Road ELGIN, IL 60123

PRINCIPAL DISPLAY PANEL 

Hydrox

Laboratories

INSTANT
HAND
SANITIZER

with moisturizers
aloe & vitamin E

KILLS 99.9%
OF GERMS*

4 FL OZ 118 mL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER UNSCENTED 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10565-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Alcohol (UNII: ND2M416302)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Aminomethylpropanol (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10565-075-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2012
2	NDC: 10565-075-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2012
3	NDC: 10565-075-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2012
4	NDC: 10565-075-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	03/21/2012

Labeler - Hydrox Laboratories (025164302)

Registrant - Hydrox Laboratories (025164302)

Establishment
Name	Address	ID/FEI	Business Operations
Hydrox Laboratories		025164302	MANUFACTURE(10565-075) , label(10565-075) , pack(10565-075)