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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gel for kids, 80ml

Active ingredient

benzalkonium chloride 0.20%

Purpose

Antiseptic

Use(s)

Use(s). Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

For external use only.

Do not use: in children less than 2 months of age; on open skin wounds.

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 Poison Control Center right away.

Directions

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.

Storage.

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

Inactive Ingredients

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

Labels (80ml)

Kids 80ml label

HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78522-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2 mg  in 80 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
WATER (UNII: 059QF0KO0R)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
BIRCH TRITERPENES (UNII: BX09B0RQR0)  
PANTHENOL (UNII: WV9CM0O67Z)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78522-101-0080 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/15/2021
Labeler - Northmed (662588132)
Establishment
NameAddressID/FEIBusiness Operations
Northmed662588132manufacture(78522-101) , pack(78522-101) , label(78522-101)

Revised: 3/2021
Document Id: bdaefe01-0467-f90c-e053-2995a90a59ca
Set id: bdaefe01-0466-f90c-e053-2995a90a59ca
Version: 1
Effective Time: 20210316
 
Northmed