Livegreen Tea Tree ANTIBACTERIAL FOAMING HAND WASH: Package Insert and Label Information

LIVEGREEN TEA TREE 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, Melaleuca Alternifolia (Tea Tree) Extract, Yellow 5, Blue 1

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LIVEGREEN TEA TREE ANTIBACTERIAL FOAMING HAND WASH
benzalkonium chloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50563-231
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
MELALEUCA ALTERNIFOLIA WHOLE
WATER
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50563-231-01 500 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 06/29/2020
Labeler — ENCHANTE ACCESSORIES INC. (186050696)
Establishment
Name Address ID/FEI Operations
Xiamen Chengda Industrial Co., Ltd 540042034 manufacture (50563-231)

Revised: 06/2020 ENCHANTE ACCESSORIES INC.

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