HAND SANITIZER  70 PERCENT- ethyl alcohol gel 
CUSTOM RESEARCH LABS INC

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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(CRL (as CMO) - CSI - HAND SANITIZER - 70% ETHYL ALCOHOL (50518-306)

ACTIVE INGREDIENT

ETHYL ALCOHOL 70%

PURPOSE

ANTIMICROBIAL

USES

WARNINGS

FOR EXTERNAL USE ONLY. DO NOT DRINK.

FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME.

DO NOT USE IN THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER, THEN CONTACT PHYSICIAN.

STOP USE AND ASK A DOCTOR IF IRRITATION AND REDNESS DEVELOP AND PERSISTS 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

PURIFIED WATER/AQUA/EAU PURIFIE, GLYCERIN, CELLULOSE

01b LBL_CSI_Hand Sanitizer_8oz_R2-3.75x5.5-final

HAND SANITIZER   70 PERCENT
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50518-306
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)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50518-306-11240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
2NDC:50518-306-12480 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/25/2020
Labeler - CUSTOM RESEARCH LABS INC (028611598)
Registrant - CUSTOM RESEARCH LABS INC (028611598)
Establishment
NameAddressID/FEIBusiness Operations
CUSTOM RESEARCH LABS INC028611598manufacture(50518-306)

Revised: 3/2022
Document Id: db64ec64-1443-4d99-e053-2a95a90add54
Set id: 7bdbd149-660c-4a1f-a38e-ac3cf9a35d56
Version: 6
Effective Time: 20220329
 
CUSTOM RESEARCH LABS INC