HANDS OUT HAND SANITIZER GEL- alcohol gel

Hands Out Hand Sanitizer Gel by

Drug Labeling and Warnings

Hands Out Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Spa Dent Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRODUCT FACTS

ACTIVE INGREDIENT

Alcohol 70% v/v

PURPOSE

Antiseptic

USE(S)

Antiseptic (skin) cleanser Medicated (skin) cleanser Antibacterial (skin) cleanser Effective in destroying (harmful) bacteria to provide antiseptic cleansing  For personal hand hygiene to help prevent the spread of bacteria

WARNINGS

For external use only. Flammable. Keep away from heat or flame.

Do not use

in children less than 2 months of age on open skin wounds.

When using this product

keep out of eyes, ears, and mouth In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

DIRECTIONS

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

Store between 15° - 30° C (59° - 86° F) out of direct sunlight Avoid freezing and excessive heat above 40° C (104° F).

Do not use this product if tamper-resistant seal is broken when opened.

INACTIVE INGREDIENTS

Purified Water, Aloe Barbadensis Leaf Juice, Vitamin E, Glycerin, Carbomer Copolymer, Aminomethyl Propanol

Package Labeling:79147-004-01

Package Labeling:79147-004-02

INGREDIENTS AND APPEARANCE

HANDS OUT HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79147-004
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79147-004-01	6 in 1 CASE	09/15/2020
1		946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 79147-004-02	12 in 1 CASE	09/15/2020
2		473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/15/2020

Labeler - Spa Dent Inc. (203478896)