ONE STEP WIPES- alcohol liquid 
BELVEDERE INTERNATIONAL 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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DRUG FACTS

ETHYL ALCOHOL 62% W/W

USE ANYTIME FOR QUICK CLEAN UP WHEN SOAP AND WATER ARE NOT AVAILABLE

KEEP OUT OF REACH OF CHILDREN

USE ANYTIME FOR QUICK CLEAN UP WHEN SOAP AND WATER ARE NOT AVAILABLE

FOR EXTERNAL USE ONLY, KEEP OUT OF REACH OF CHILDREN, FLAMMABLE, KEEP AWAY FROM OPEN FLAME AND SOURCES OF HEAT. AVOID CONTACT WITH EYES SHOULD THIS OCCUR FLUSH EYES WITH WATER. IF IRRITATION DEVELOPS, DISCONTINUE USE AND CONTACT A PHYSICIAN. IF SWALLOWED, CONTACT A PHYSICIAN. DO NOT STORE ABOVE 40 ​0 ​C/110 ​0​F

TEAR OPEN PACKET. UNFOLD TOWEL AND WIPE HANDS THOROUGHLY

WATER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS EXTRACT, HYDROXYPROPYLCELLULOSE, ISOPROPYL ALCOHOL, PARFUM, PEG-7 GLYCERYL COCOATE, TETRAHYDROXYPROPYL ETHYLENEDIAMINE.

OUTER PACKAGE IMAGEINNER PACKAGE IMAGE

ONE STEP WIPES 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60742-200
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)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60742-200-0212 in 1 PACKAGE12/13/2018
1NDC:60742-200-013 mL in 1 POUCH; Type 0: Not a Combination Product
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(60742-200)

Revised: 12/2018
Document Id: 7cf01a53-2d9c-5012-e053-2a91aa0ac1fe
Set id: 597f533e-077f-48b8-b4ba-2ed640fb897c
Version: 2
Effective Time: 20181213
 
BELVEDERE INTERNATIONAL INC.