Your browser does not support JavaScript! ONE STEP HAND SANITIZER ALOE (ALCOHOL) GEL [BELVEDERE INTERNATIONAL INC.]
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ONE STEP HAND SANITIZER ALOE (alcohol) gel
[BELVEDERE INTERNATIONAL INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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 DRUG LABELItem Code (Source)NDC:60742-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYSORBATE 20 
ALOE VERA LEAF 
CARBOMER 934 
ISOPROPYL ALCOHOL 
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
 
BELVEDERE INTERNATIONAL INC.

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