Hand Sanitizer Gel by New Directions Aromatics Inc. HAND SANITIZER GEL gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by New Directions Aromatics Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 65%. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

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

This product contains a chemical that is currently listed under California's Proposition 65.

DO NOT USE

-In children less than 2 months of age.

-On open skin wounds

WHEN USING

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

STOP USE

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

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

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Purified Water, Glycerin, Polyquaternium-37, Aloe Barbadensis Leaf Juice

PRINCIPAL DISPLAY PANEL

NDC 473 mL: 74179-800-01

NDC 200L: 74179-800-02

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74179-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.65 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	0.33199 mL  in 1 mL
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)	0.008 mL  in 1 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.00001 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.01 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74179-800-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
2	NDC: 74179-800-02	200000 mL in 1 DRUM; Type 0: Not a Combination Product	04/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/16/2020

Labeler - New Directions Aromatics Inc. (200570278)

Registrant - New Directions Aromatics Inc. (200570278)

Establishment
Name	Address	ID/FEI	Business Operations
New Directions Aromatics Inc.		200570278	manufacture(74179-800)