PUMPKIN ANTI-BACTERIAL FOAMING HAND WASH- benzethonium chloride liquid 
Tonic Bath and Body Products Shenzhen 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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Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.


When using this product

Avoid contact with eyes. If contact occurs flush eyes with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.


Keep out of the reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Wet hands. Apply palmful to hands and forearms. Scrub thoroughly. Rinse and repeat. Dry thoroughly.

Inactive Ingredients

Water (Aqua), Sodium Lauroamphoacetate, Cocomidopropylamine Oxide, Cocamidopropyl Betaine, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Olea Europaea (Olive) Leaf Extract, Fragrance (Parfume), Polyaminopropyl Biguanide, Thymus Vulgaris (Thyme) Oil, Citric Acid, Methylchloroisothiazolinone $ Methylisothiazolinone, Disodium EDTA, Benzophenone-3. May contain: FD&C Red NO. 40 (CI 16035), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090).

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PUMPKIN ANTI-BACTERIAL FOAMING HAND WASH 
benzethonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43333-441
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 13 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
EDETIC ACID (UNII: 9G34HU7RV0)  
OXYBENZONE (UNII: 95OOS7VE0Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43333-441-10296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/24/201401/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/24/201401/19/2023
Labeler - Tonic Bath and Body Products Shenzhen Ltd. (528197042)
Establishment
NameAddressID/FEIBusiness Operations
Tonic Bath and Body Products Shenzhen Ltd.528197042manufacture(43333-441)

Revised: 1/2023
 
Tonic Bath and Body Products Shenzhen Ltd.