CENTROLL NAP ADVANCED HAND SANITIZER GEL- alcohol gel 
SUNGIN PHARMA

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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[82037-510-01] [Gel] [Bottle+Pump] [500 mL] Centroll NAP ADVANCED Hand Sanitizer Gel

Active ingredient

Alcohol 70 %

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin.

For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

■ in children less than 2 months of age ■ on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

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

Directions

■ Place enough product on hands to cover all surfaces. Rub hand together until dry.

■ Apply it in a well-ventilated area.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)

■ This product is intended only for hand sanitizing.

■ To prevent contents from drying out and contaminants from entering, close lid completely after use.

■ Keep product in its original container as storing the product in anything other than the original container may result in accidents or cause the integrity of the product to diminish.

■ Do not use over bandages, castings, etc. as irritation may occur.

Other information

■ Store between 15-30 °C (59-86 °F)

■ Avoid freezing and excessive heat above 40 °C (104 °F)

Inactive ingredients

Water, Citric acid, Aminomethylpropanol, Urea, Carbomer homopolymer,Tocopherol acetate, Isopropyl myristate, Glycerin, Dexpanthenol, Glycyrrhiza Glabra (Licorice) Root Extract

Centroll NAP ADVANCED Hand Sanitizer Gel

CENTROLL NAP ADVANCED HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82037-510
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
UREA (UNII: 8W8T17847W)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82037-510-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/22/2021
Labeler - SUNGIN PHARMA (688719819)
Establishment
NameAddressID/FEIBusiness Operations
SUNGIN PHARMA688719819manufacture(82037-510)

Revised: 7/2021
Document Id: c7aed8cf-bdbb-5940-e053-2995a90a881b
Set id: c7aed8cf-bdba-5940-e053-2995a90a881b
Version: 1
Effective Time: 20210721
 
SUNGIN PHARMA