HAND SANITIZER- hand soap gel 
Shenzhen Derun'en Science & Technology Development 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.

----------

HAND SANITIZER

Active Ingredient(s)

Absolute ethanol Alcohol 75% v/v. glycerin 1%......Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

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.

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

Other information

Keep tightly closed in a cool, dark, dry place. Save below 30℃.

Inactive ingredients

Carbomer

Package Label - Principal Display Panel

500ML IN 1 BOTTLE NDC:55029-002-01

500ML

1000ML IN 1 BOTTLE NDC:55029-002-02 1000ML

product

HAND SANITIZER 
hand soap gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55029-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 mg  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55029-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:55029-002-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Shenzhen Derun'en Science & Technology Development Co., Ltd (550292933)
Registrant - Shenzhen Derun'en Science & Technology Development Co., Ltd (550292933)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Derun'en Science & Technology Development Co., Ltd550292933manufacture(55029-002) , label(55029-002)

Revised: 11/2020
Document Id: b4a8b7bc-07b2-8d99-e053-2995a90a3f08
Set id: a985ba81-efc1-00a1-e053-2995a90a00ec
Version: 3
Effective Time: 20201121
 
Shenzhen Derun'en Science & Technology Development Co., Ltd