HAND SANITIZER- benzalkonium chloride gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Northmed. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride, .2%. Purpose: Antiseptic

Purpose

Antiseptic

Use

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.

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 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.

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.

Directions

Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 41-80F (5-27C).
• Avoid freezing and excessive heat above 104F (40C).

Inactive ingredients

Water. glycerin, panthenol, aloe vera, hydroxyethyl cellulose, tetrasodium glutamate diacetate, fragrance, chamomile extract, birch leaf extract, elderberry extract

Package Label - Principal Display Panel

4L NDC: 78522-101-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78522-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	2 mg  in 4 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
WATER (UNII: 059QF0KO0R)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PANTHENOL (UNII: WV9CM0O67Z)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BIRCH TRITERPENES (UNII: BX09B0RQR0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78522-103-00	4 L in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Northmed (662588132)

Establishment
Name	Address	ID/FEI	Business Operations
Northmed		662588132	manufacture(78522-103) , pack(78522-103) , label(78522-103)