NEW LIFE MOISTURIZING HAND SANITIZER- ethanol gel

new life Moisturizing Hand Sanitizer by

Drug Labeling and Warnings

new life Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by AFAM Concept, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active Ingredient

Ethanol 70%

Purpose

Antiseptic

INDICATIONS & USAGE

Uses Hand sanitizer to decrease bacteria on skin Recommended for repeated use

WARNINGS

Warning For external use only

Flammable. Keep away from fire or flame.

When using this product avoid contact with face, eyes and broken skin. If eye contact occurs, flush thoroughly with water and seek medical advice.

Stop use and ask doctor if irritation and redness develops.

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions Wet hands thoroughly with product and rub into skin until dry. Children under 6 years of age should be supervised by an adult when using this product.

INACTIVE INGREDIENT

Inactive Ingredients: Water (Aqua), Polysorbate 20, Isopropyl Alcohol, Tocopheryl Acetate, Panthenol, Methyl Gluceth-20, Acrylates/C10-30 Akyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum).

SPL UNCLASSIFIED SECTION

new life™

ADVANCED FORMULA

Moisturizing Hand Sanitizer with Vitamin E & B5

Kills Germs +

Helps Reduce The Risk Of Infections

ORIGINAL

MADE IN USA

AFAM CONCEPT, Inc. Chicago, IL 60629

Watford WD24 7GN, UK 800-262-2326

Packaging

INGREDIENTS AND APPEARANCE

NEW LIFE MOISTURIZING HAND SANITIZER 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49681-100
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)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
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: 49681-100-05	4.44 mL in 1 POUCH; Type 0: Not a Combination Product	03/27/2020
2	NDC: 49681-100-20	52 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
3	NDC: 49681-100-10	59 mL in 1 TUBE; Type 0: Not a Combination Product	03/27/2020
4	NDC: 49681-100-40	112 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
5	NDC: 49681-100-80	228 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
6	NDC: 49681-100-29	858 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
7	NDC: 49681-100-14	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

Labeler - AFAM Concept, Inc. (047821728)

Establishment
Name	Address	ID/FEI	Business Operations
AFAM Concept, Inc.		047821728	manufacture(49681-100)