FOLKS ALCOHOL FREE HAND SANITIZER FOAM- benzalkonium chloride liquid 
WORLDCHEM CO LTD

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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Benzalkonium Chloride 0.1%

Water, Glycerin, 1.2-Hexandiol, Polysorbate-80, Sodium Hyaluronate, Cetrimonium Chloride , Lemon Oil, Citric Acid

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic to decrease bacteria on the skin

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■ Do not use in combination with soap or antibacterial cleansing agents.

• Keep Out of Reach of Children.

■ spray a small amount into hands, spread evenly and rub into the skin

for topical use only

label

FOLKS ALCOHOL FREE HAND SANITIZER FOAM 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74538-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74538-0008-150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/04/2020
Labeler - WORLDCHEM CO LTD (631058864)
Registrant - WORLDCHEM CO LTD (631058864)
Establishment
NameAddressID/FEIBusiness Operations
WORLDCHEM CO LTD631058864manufacture(74538-0008)

Revised: 5/2020
Document Id: a6d75952-7cd7-0b27-e053-2a95a90a0f0e
Set id: a2771fb9-adc8-0d87-e053-2a95a90aa915
Version: 2
Effective Time: 20200530
 
WORLDCHEM CO LTD