BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH MINT AND TEA TREE- benzalkonium chloride solution

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH Mint and Tea Tree by

Drug Labeling and Warnings

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH Mint and Tea Tree by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC., Xiamen Chengda Industrial Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH MINT AND TEA TREE 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-235
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-235-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/30/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Chengda Industrial Co., Ltd		540042034	manufacture(50563-235)