HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients

Ethyl alcohol 65.6%

Purpose

Antiseptic

Uses

• hand sanitizer to help reduce bacteria that potentially may cause disease.

Warnings

For external use only

Flammable, keep away from fire or flame.

When using this product

• keep out of eyes.  In case of contact with eyes, flush thoroughly with water.
• avoid contact with broken skin.
• do not inhale or ingest

Stop use and ask a doctor if

• irritation and redness develop.
• condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hands thoroughly with product and rub into skin until dry.
• children under 6 years of age should be supervissed by an adult when using this product.

Inactive ingredients

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propylene Glycol, Triethanolamine, Panthenol, Aloe Barbadensis Leaf Juice, Maltodextrin, Sodium Benzoate, Potassium Sorbate

Package Labeling:

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.656 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-405-01	400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/20/2020

Labeler - Access Business Group LLC (839830713)

Establishment
Name	Address	ID/FEI	Business Operations
Access Business Group LLC		839830713	manufacture(10056-405) , label(10056-405) , pack(10056-405)