JANSSEN IMMUNOLOGY HAND SANITIZER 59ML- alcohol gel 
Shenzhen Lantern Scicence 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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Janssen Immunology Hand sanitizer 59ml

Drug Facts

54860-342-01

Active Ingredient

Active Ingredient Purpose

Ethyl Alcohol 70%（V/V） Antiseptic

Uses

For hand sanitizing to reduce bacteria on the skin.

Recommended for repeated use.

use anywhere without water.

Warnings

For external use only-hands.

Flammable.

Keep away from heat and flame.

For external use only.

Flammable, keep away from heat and flame.

Discontinue if skin becomes irritated and ask a doctor .

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poson control center immediately.

Inactive ingredients

Aqua,Glycerin,Aloe Yohjyu Matsu Ekisu,Tocopheryl Acetate,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Aminomethyl Propanol,Parfum.

Directions

squeeze small amount in your palm and briskly rub hands together until dry.

When using this product

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

Do not inhale or ingest.

Avoid contact with broken skin.

Other information

Do not store above 105F.

May discolor some fabrics.

Harmful to wood finishes and plastics.

54860-342-01.

JANSSEN IMMUNOLOGY HAND SANITIZER 59ML 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-342
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE ANDONGENSIS WHOLE (UNII: XOQ5N25YKS) 0.05 mL  in 100 mL
ALOE (UNII: V5VD430YW9) 0.1 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 0.3 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.12 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.929 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 mL  in 100 mL
Product Characteristics
Colorwhite (transparant) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54860-342-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/26/2020
Labeler - Shenzhen Lantern Scicence Co Ltd (421222423)
Registrant - Lantern Beauty America,INC. (117371139)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Lantern Science Co.,Ltd.421222423manufacture(54860-342)

Revised: 11/2020
Document Id: b50fab1a-4c70-7311-e053-2995a90a8cd8
Set id: b50f9f15-f7c6-0b63-e053-2995a90ae7cf
Version: 16
Effective Time: 20201126
 
Shenzhen Lantern Scicence Co Ltd