Livegreen Eucalyptus Mint ANTIBACTERIAL FOAMING HAND WASH: Package Insert and Label Information

LIVEGREEN EUCALYPTUS MINT ANTIBACTERIAL FOAMING HAND WASH- 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.

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

■ To decrease bacteria on hands

WARNINGS

For external use only

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

keep out of reach of children

Keep out of reach of children

Directions

Pump soap into dry hands. Lather for at least 20 seconds and rinse thoroughly

Inactive ingredients

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Eucalyptus Globulus Leaf Extract, Mentha Arvensis
Extract, Yellow 5, Blue 1

LIVEGREEN EUCALYPTUS MINT ANTIBACTERIAL FOAMING HAND WASH benzalkonium chloride solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-233 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 mL

Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL BETAINE DMDM HYDANTOIN DISODIUM HEDTA CITRIC ACID MONOHYDRATE EUCALYPTUS GLOBULUS LEAF WATER FD&C YELLOW NO. 5 FD&C BLUE NO. 1 MENTHA ARVENSIS WHOLE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50563-233-01 500 mL in 1 BOTTLE None

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	Operations
Xiamen Chengda Industrial Co., Ltd		540042034	manufacture (50563-233)

Revised: 06/2020 ENCHANTE ACCESSORIES INC.