ONE STEP HAND SANITIZER ALOE- alcohol gel 
BELVEDERE INTERNATIONAL INC.
Reference Label Set Id: 711e7953-33f1-48ad-af74-16f25341c404

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.

----------

DRUG FACTS

DRUG FACTS

Active Ingredient

Ethyl Alcohol 62%

USE WHENEVER SOAP AND WATER ARE NOT AVAILABLE AND TO SUPPLEMENT ROUTING HAND WASHING

CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SURPERVISED WHEN USING THIS PRODUCT, KEEP OUT OF REACH OF CHILDREN

USE WHENEVER SOAP AND WATER ARE NOT AVAILABLE AND TO SUPPLEMENT ROUTINE HAND WASHING, APPLY LIBERALLY TO HAND AND RUB THOROUGHLY UNTIL DRY

FOR EXTERNAL USE ONLY, KEEP OUT OF REACH OF CHILDREN, FLAMMABLE, AVOID CONTACT WITH EYES SHOULD THIS OCCUR FLUSH WITH WATER DISCONTINUE USE IF IRRITATION DEVELOPS, IF CONDITION PERSISTS FOR MORE THAN 72 HOURS CONSULT YOUR PHYSICIAN. IF SWALLOWED CONTACT A PHYSICIAN AS WELL, DO NO STORE ABOVE 40​0 ​C/110​0​F

APPLY LIBERALLY TO HAND AND RUB THOROUGHLY UNTIL DRY

WATER, ISOPROPYL ALCOHOL, CARBOMER, ALOE VERA LEAF, POLYSORBATE 20, PARFUM



IMAGE OF FRONT AND BACK LABEL 236ML
IMAGE OF FRONT AND BACK LABEL 1L
IMAGE OF FRONT AND BACK LABEL 60ML



ONE STEP HAND SANITIZER ALOE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60742-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 934 (UNII: Z135WT9208)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60742-001-01236 mL in 1 BOTTLE, PUMP
2NDC:60742-001-0260 mL in 1 BOTTLE
3NDC:60742-001-031000 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/31/2012
Labeler - BELVEDERE INTERNATIONAL INC. (247836356)
Registrant - BELVEDERE INTERNATIONAL INC. (247836356)
Establishment
NameAddressID/FEIBusiness Operations
BELVEDERE INTERNATIONAL INC.247836356manufacture(60742-001)

Revised: 9/2013
Document Id: 446a696f-296f-45e3-abd2-d87b5d6e47e8
Set id: 614a321a-5a3e-4516-899b-ea216870b585
Version: 4
Effective Time: 20130911
 
BELVEDERE INTERNATIONAL INC.