HAND SANITIZER- benzalkonium chloride gel 
Northmed

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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 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

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

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

Kids 4L label4L NDC: 78522-101-01

HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78522-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2 mg  in 4 L
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78522-103-004 L in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Northmed (662588132)
Establishment
NameAddressID/FEIBusiness Operations
Northmed662588132manufacture(78522-103) , pack(78522-103) , label(78522-103)

Revised: 3/2021
Document Id: be4ff9f3-9efa-36ca-e053-2a95a90ab0ef
Set id: be507751-ba1b-4ff2-e053-2995a90a7176
Version: 1
Effective Time: 20210324
 
Northmed