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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:60742-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 934 (UNII: Z135WT9208)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60742-001-01 236 mL in 1 BOTTLE, PUMP
2 NDC:60742-001-02 60 mL in 1 BOTTLE
3 NDC:60742-001-03 1000 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 01/31/2012
Labeler - BELVEDERE INTERNATIONAL INC. (247836356)
Registrant - BELVEDERE INTERNATIONAL INC. (247836356)
Establishment
Name Address ID/FEI Business Operations
BELVEDERE INTERNATIONAL INC. 247836356 manufacture(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.