HAND SANITIZER- hand sanitizer gel 
China Ningbo Shangge Cosmetic Technology Corp.

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)

Ethyl Alcohol 70.0%V/v

Purpose

Antimicrobial

Use

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

Warnings

For extemal use only. Flammable, Keep away from heat or flame

Do not use

● on infants
● 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 lf irritation or rash occurs. these may be signs of a serious condition.

Stop use and ask a doctor lf 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

● Apply as needed into palm of hand and thoroughly spread on both hands, rub until dry.
● Supervise children under 6 years of age when using thisproduct.

Other information

● Store between15-30°c(59-86°F)
● Avoid freezing and excessive heat above40°c(104°F)

Inactive ingredients

Deionized water, Triethanolamine, Carbomer,Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Tocophe Acetate

Package Label - Principal Display Panel

32

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-804
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 VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-804-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:58503-804-02473 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 - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-804)

Revised: 6/2020
Document Id: a7b891d0-9a5c-81d8-e053-2a95a90a279b
Set id: a7b891d0-9a5d-81d8-e053-2a95a90a279b
Version: 1
Effective Time: 20200610
 
China Ningbo Shangge Cosmetic Technology Corp.