HAND CLEANER HAND SANITIZER- alcohol gel 
i9biz, 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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Active Ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease

recommended for repeated use

Warnings

For external use only: hands

Flammable, keep away from fire or flame

When using this product

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

avoid contact with broken skin

do not inhale or ingest

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

Directions

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Other information

do not store above 105F

may discolor some fabrics

harmful to wood finishes and plastics

Inactive ingredients

Water, Sodium Hyaluronate, Glycerin, 1,2-Hexanediol, Triethanolamine, Carbomer, Panthenol, Propylene Glycol, Glycyrrhiza Glabra (licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Schisandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Camellia Sinensis Leaf Extract, Propolis Wax, Butylene Glycol, Asiaticoside, Citrus Paradisi (Grapefruit) Fruit Extract, Pinus Sylvestris Leaf Extract, Caprylyl Glycol

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label

NDC 74429 311 Label

HAND CLEANER HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74429-311
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.035 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 35.2245 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.45 mL  in 100 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.005 mL  in 100 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G) 0.03 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.2 mL  in 100 mL
COPTIS JAPONICA ROOT (UNII: JH0SWT16D1) 0.005 mL  in 100 mL
PROPOLIS WAX (UNII: 6Y8XYV2NOF) 0.0025 mL  in 100 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.055 mL  in 100 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.0025 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.35 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.35 mL  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z) 0.3 mL  in 100 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) 0.05 mL  in 100 mL
SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C) 0.005 mL  in 100 mL
GINGER (UNII: C5529G5JPQ) 0.005 mL  in 100 mL
GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.005 mL  in 100 mL
ASIATICOSIDE (UNII: PKO39VY215) 0.0005 mL  in 100 mL
GRAPEFRUIT (UNII: O82C39RR8C) 0.435 mL  in 100 mL
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) 0.49 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74429-311-0127 mL in 1 POUCH; Type 0: Not a Combination Product04/10/2020
2NDC:74429-311-0250 mL in 1 TUBE; Type 0: Not a Combination Product04/10/2020
3NDC:74429-311-03100 mL in 1 TUBE; Type 0: Not a Combination Product04/10/2020
4NDC:74429-311-04300 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/10/2020
5NDC:74429-311-05300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/10/2020
6NDC:74429-311-06500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/10/2020
Labeler - i9biz, Inc (064260178)
Registrant - BL Cosmetic Co., Ltd (695735124)
Establishment
NameAddressID/FEIBusiness Operations
BL Cosmetic Co., Ltd695735124manufacture(74429-311)

Revised: 4/2020
Document Id: a250577c-2ff5-757c-e053-2a95a90ad88b
Set id: a250577c-2ff4-757c-e053-2a95a90ad88b
Version: 1
Effective Time: 20200402
 
i9biz, Inc