70% ALCOHOL/ALCOOL HAND SANITIZER- hand sanitizer gel 
Sanrace Biotechnology 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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Sanrace, Sanitizer, 70% Alcohol, Gel, 55mL

Active Ingredient(s)

Alcohol 70% v/v. 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

Flammable. For external use only. 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 and redness develop and persist for more than 72 hours.

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, Propylene Glycol, Carbomer, Aloe Yohjyu Matsu Ekisu, Triethanolamine, Disodium Edta.

Package Label - Principal Display Panel

55

70% ALCOHOL/ALCOOL HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75448-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL38.5 mL  in 55 mL
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75448-011-0555 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/21/2020
Labeler - Sanrace Biotechnology Co., Ltd (543000938)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Sanrace Biotechnology Co., Ltd543000938label(75448-011) , manufacture(75448-011)

Revised: 4/2020
Document Id: a3e68e85-d1e0-9cec-e053-2995a90adb11
Set id: a3e68e85-d1df-9cec-e053-2995a90adb11
Version: 1
Effective Time: 20200422
 
Sanrace Biotechnology Co., Ltd