BONANGE HAND CLEANER- alcohol gel 
Mi-face Co., Ltd

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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Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENT: ALCOHOL 62.0% w/w

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

Water, Glycerin, Phenoxyethanol, Carbomer, Triethanolamine, Butylene Glycol, 1,2-Hexanediol, PEG-60 Hydrogenated Castor Oil, Lavandula Angustifolia (Lavender) Oil, Opuntia Ficus-Indica Extract, Bambusa Vulgaris Leaf/Stem Extract, Avena Sativa (Oat) Kernel Extract, Luffa Cylindrica Fruit Extract, Aloe Barbadensis Leaf Extract, Salvia Hispanica Seed Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter Extract, Scutellaria Baicalensis Extract, Laminaria Japonica Extract, Ethylhexylglycerin

PURPOSE

PURPOSE: ANTISEPTIC

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses:

Uses

■ Hand sanitizer to help reduce bacteria that potentially can cause disease.

WARNINGS

Warnings:

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

Directions:

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Other information
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Package Label: BONANGE HAND CLEANER 3mL * 100ea

Image of carton

BONANGE HAND CLEANER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75005-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1.86 mL  in 3 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Trolamine (UNII: 9O3K93S3TK)  
Butylene Glycol (UNII: 3XUS85K0RA)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
PEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
OPUNTIA FICUS-INDICA WHOLE (UNII: 23Z87HTQ6P)  
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
OAT (UNII: Z6J799EAJK)  
LUFFA AEGYPTIACA FRUIT (UNII: QKL9NEO1F9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHIA SEED (UNII: NU0OLX06F8)  
COCONUT (UNII: 3RT3536DHY)  
SHEA BUTTER (UNII: K49155WL9Y)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
LAMINARIA JAPONICA (UNII: WE98HW412B)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75005-030-02100 in 1 CARTON05/01/2020
1NDC:75005-030-013 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - Mi-face Co., Ltd (694820628)
Registrant - Mi-face Co., Ltd (694820628)
Establishment
NameAddressID/FEIBusiness Operations
Mi-face Co., Ltd694820628manufacture(75005-030)

Revised: 5/2020
Document Id: 1d07dfe6-f4f3-4bd1-9b74-5eb0fa64eb5e
Set id: 6c9fc64c-aea9-4748-8fda-380055d23e2f
Version: 1
Effective Time: 20200509
 
Mi-face Co., Ltd