HOME HAND SANITIZER- alcohol gel

Home Hand Sanitizer by

Drug Labeling and Warnings

Home Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by UNIWARE HOUSEWARE CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 70% v/v. 

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria  on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product avoid contact with face, eyes and broken skin. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness appears and lasts.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Put enough product in your palm to cover hands and rub hands until dry.
• Children under 6 years of age should be supervised when using the product.

Other information

• Store below 110° F (43° C).
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water (Aqua), lsopropyl Alcohol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 2-amino-2-methyl-1-propanol.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HOME HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78712-001
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
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78712-001-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2020
2	NDC: 78712-001-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2020
3	NDC: 78712-001-03	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2020
4	NDC: 78712-001-04	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2020
5	NDC: 78712-001-05	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2020
6	NDC: 78712-001-06	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2020
7	NDC: 78712-001-07	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2020
8	NDC: 78712-001-08	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2020
9	NDC: 78712-001-09	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/22/2020

Labeler - UNIWARE HOUSEWARE CORP. (931896372)