BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH MINT AND TEA TREE- 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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G0ABHW05

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, Mentha Arvensis Extract, Melaleuca Alternifolia (Tea Tree) Extract, Benzoic Acid, Blue 1, Yellow 5

image description

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH MINT AND TEA TREE 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-235
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)  
MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O)  
MELALEUCA ALTERNIFOLIA WHOLE (UNII: 976KV4FXYF)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-235-01500 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(50563-235)

Revised: 6/2020
Document Id: a9536315-63fc-0318-e053-2a95a90a8850
Set id: 4c4110a8-9de2-4859-98c3-f0f7e9b70a16
Version: 1
Effective Time: 20200630
 
ENCHANTE ACCESSORIES INC.