DRUG FACTS

ONE STEP HAND SANITIZER - alcohol gel
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%

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

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

ONE STEP 473mL

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 EYES 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 NOT STORE ABOVE 40 0 C/110 0F

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

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

IMAGE OF PRODUCT LABEL ONE STEP 473mL.jpg

ONE STEP HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60742-473
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 934 (UNII: Z135WT9208)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60742-473-01	473 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	01/27/2012

Labeler - Belvedere International Inc. (247836356)

Name	Address	ID/FEI	Business Operations
Establishment
Belvedere International Inc.		247836356	manufacture