HAND SANITIZER HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

• Active ingredient: Purpose
• Ethyl Alcohol 70%: Antiseptic

Inactive Ingredients

Water (Aqua)

Aloe Barbadensis Leaf Juice (Stabilized* Aloe Vera Gel)

Isopropyl Alcohol

Glycerin

Tetrahydroxypropyl Ethylenediamine

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Tocopheryl Acetate
Isopropyl Myristate.

Purpose Section

Uses

Hand sanitizer to help decrease bacteria on the skin.

When water, soap & towel are not available.

Recommended for repeated use.

Warnings

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Indications & Usage

When using this product, avoid contact with eyes.

In case of contact flush eyes with water.

Do not apply around eyes. Do not use in ears & mouth.

Stop use and ask a doctor if

Stop use and ask a doctor if

• Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

Keep out of reach of children

Keep out of reach of children. Children must be supervised in use of this product.

Dosage & Administration Directions

Directions

• wet hands thoroughly with product
• briskly rub hands together until dry
• children under 6 years of age should be supervised when using this product
  

Other information

• store at 20 °C to 25 °C (68°F to 77°F) when possible. Do not store above 40 °C (104° F).
• may discolor certain fabrics
  

Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER  HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46432-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETOL (UNII: Q4R969U9FR)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46432-121-01	60 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2020

Labeler - Dhaliwal Laboratories, LLC (016754201)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Laboratories,LLC		016754201	manufacture(46432-121)