BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH LEMON VERBENA- benzalkonium chloride solution 
ENCHANTE ACCESSORIES 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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G0ABHW07

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

■ For hand washing to decrease bacteria on hands

WARNINGS

For external use only - hands

When Using this Product

Keep out of eyes. In case of contact with eyes, flush thoroughly with water

Stop use and ask a doctor if skin irritation develops. 

keep out of reach of children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

Directions

Apply a small amount to hands. Lather for at least 20 seconds then rinse with warm water

Avoid contact with eyes

Not recommended for infants

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Cocamidopropyl Betaine, PEG-150 Distearate, Cocamide MEA, Benzyl Alcohol, Fragrance, Phenoxyethanol, Sodium
Hydroxide, Tocopheryl Acetate, Benzoic Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Verbena Officinalis Extract, Yellow 5, Red 4

image description

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH LEMON VERBENA 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-237
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VERBENA OFFICINALIS (UNII: QT8A71T9BM)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-237-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/30/2020
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Chengda Industrial Co., Ltd540042034manufacture(50563-237)

Revised: 6/2020
Document Id: a9536315-6409-0318-e053-2a95a90a8850
Set id: 85f050b4-5abe-4e18-af83-d19b68e8a248
Version: 1
Effective Time: 20200630
 
ENCHANTE ACCESSORIES INC.