DR.CLEANEW HAND SANITIZER- alcohol liquid 
NR 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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SANITIZER

PURPOSE

Antimicrobial

Active Ingredients

ALCOHOL

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.
Recommended for external use only.

Warnings

For external use only

Keep away from fire of flame

Do not spray on clothes because it can stain.

Be caeful not to get into your eyes, and if so wash thoroughly with water

Keep out of reach of children

Keep out of reach of children.

Stop use and ask a doctor

Take care not to get into the eye.

If a children has swallowed it go to the hospital immediately and see a doctor

Other information

beause replacing in other containers can cause accidents or deteriorate quality, put it in the original container and keep

it tightly closed.

store away from high temperature and fire.

indication

sprinkle evenly on your hands

do not use

do not use on intraoral, mucosal and damaged skin

carefully use for the people with allergic reactions,

immediately discontinue use and consult a dermatologist if hypersensitivity symptoms

such as rash itching etc occur

skin irritation symptoms occur

inactive ingredient

water, citric acid

Direction

disinfection of hands and skin

Spray on hands or spray where disinfection is needed

label

79191-301-01

79191-301-01

79191-301-02

79191-301-02

DR.CLEANEW HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79191-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 39.5 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79191-301-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/25/2020
2NDC:79191-301-02500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/25/2020
Labeler - NR CO.,Ltd. (690430136)
Registrant - NR CO.,Ltd. (690430136)
Establishment
NameAddressID/FEIBusiness Operations
NR CO.,Ltd.690430136manufacture(79191-301)

Revised: 6/2020
Document Id: a8ce764e-77e1-776f-e053-2995a90ae1b7
Set id: a8ce764e-77e0-776f-e053-2995a90ae1b7
Version: 1
Effective Time: 20200624
 
NR CO.,Ltd.