HYDRATING HAND SAINTIZER- ethyl alcohol gel

Hydrating Hand Saintizer by

Drug Labeling and Warnings

Hydrating Hand Saintizer by is a Otc medication manufactured, distributed, or labeled by Monfitello Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 70%

PURPOSE

Purpose -Antiseptic Skin cleanser 

INDICATIONS & USAGE

Use

• Antiseptic Skin cleanser

WARNINGS

Warnings

Keep away from open flame & sources of heat.

For extenal use only.

KEEP OUT OF REACH OF CHILDREN

Keep out of children

If accidently swallowed, call a posion control center or get medical help right away.

USER SAFETY WARNINGS

Do not get into eyes

If contact occurs, rinse thoroughly with water

DOSAGE & ADMINISTRATION

• Children,adolescents and adults 2 years and over.
• for occasional and personal domestic use
• supervise children when they use this product.
• Place enough product on your plam to thoroughly cover your hands.
• rub thoroughly into hands for at least 30 seconds
• Allow to dry.

OTHER SAFETY INFORMATION

Other Information

• May discolor certain fabrics or surfaces
• do not store above 110 F ( 43 C)

INACTIVE INGREDIENT

Distilled Water, Vegetable Glycerin, Carbomer Polymer, Triethanolamine, Grapefruit essential oil blend, Aloe Barbadensis Leaf Juice, Vitamin E Extract, Denatonium Benzoate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRATING HAND SAINTIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81170-001
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
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
WATER (UNII: 059QF0KO0R)
GRAPEFRUIT OIL (UNII: YR377U58W9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81170-001-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2020
2	NDC: 81170-001-12	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/20/2020

Labeler - Monfitello Inc (243794851)