SANITIZING HAND- benzethonium chloride lotion 
BELLA BRANDS INC

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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Sanitizing Hand

Drug Facts:

Active Ingredient

Benzethonium Chloride, 0.1%

Purpose

Antimicrobial Agent

Use

for moisturizing hands and decreasing bacteria on the skin.

Warnings

- For external use only.

- Do not use if you are allergic to any of the ingredients.

- When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water.

- Stop use and consult a doctor if irritation or rash develops and continues for more than 72 hours.

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

Inactive Ingredients

Water, Ethyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Caprylic/ Capric Triglyceride, Potassium Cetyl Phosphate, Sorbitan Isostearate, Diheptyl Succinate & Capryloyl Glycerin/Sebacic Acid Copolymer, Stearic Acid, Chlorohexidine Gluconate, Carbomer, Polysorbate 20, Aminomethyl Propanol, Tetrasodium EDTA, Camellia Sinensis (Green Tea) Extract1, Glycirrhiza Glabra (Licorice) Root Extract1, Aloe Vera Barbadensis Leaf Juice1, Chamomilla Recutita (Matricaria) Flower Extract1, Phenoxyethanol, Ethylglycerin, Fragrance (Naturally Derived)


1
Organic Ingredient

Directions For Use

- Press dispensing pump to release product into hands, and rub thoroughly around both sides of hands and between fingers. Do not wipe off. Let air dry.

- For adults and children 2 years and over.

- For children under 2 years of age, consult a doctor before use

PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label

PURIGEN™

Sanitizing
Hand Lotion

Paraben Free
No Artificial Fragrance
Made with Organic Ingredients

13.5 fl oz (400 ml)

PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label
SANITIZING HAND 
benzethonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80994-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
EDETATE SODIUM (UNII: MP1J8420LU)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LICORICE (UNII: 61ZBX54883)  
CHAMOMILE (UNII: FGL3685T2X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-AMINOBUTYRIC ACID, L- (UNII: 0QAJ5KN9IM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80994-002-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC:80994-002-02400 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
3NDC:80994-002-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
4NDC:80994-002-04150 in 1 BOX05/01/2020
41.2 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A05/01/2020
Labeler - BELLA BRANDS INC (034908755)
Establishment
NameAddressID/FEIBusiness Operations
BELLA BRANDS INC034908755MANUFACTURE(80994-002)

Revised: 11/2020
Document Id: 523387a7-81dc-4354-897d-76d5f0b037c5
Set id: 02931a92-714a-498d-9d54-4cf778be94de
Version: 1
Effective Time: 20201118
 
BELLA BRANDS INC