HYDRATING ANTI-BACTERIAL HAND SANITIZER- alcohol lotion 
SHISEIDO AMERICAS CORPORATION

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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Hydrating Anti-Bacterial Hand Sanitizer

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Use

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

water, glycerin, carbomer, triethanolamine

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

SHISEIDO
AMERICAS

Hydrating Anti-Bacterial
Hand Sanitizer

THE
BEAUTY OF HELPING
OTHERS

SERVING OUR
COMMUNITIES

Label donated by
Standwill Packaging

3.4 FL. OZ. (100 mL)

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
HYDRATING ANTI-BACTERIAL HAND SANITIZER 
alcohol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-535
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-535-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
2NDC:58411-535-11150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
3NDC:58411-535-123785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E04/01/2020
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICAS INC.782677132MANUFACTURE(58411-535) , ANALYSIS(58411-535)

Revised: 4/2020
Document Id: d2430121-cf15-4f9a-90e0-81614983acc0
Set id: a53037fd-4018-4711-a39d-20e33bea773f
Version: 1
Effective Time: 20200401
 
SHISEIDO AMERICAS CORPORATION