Label: ONE STEP HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 60742-473-01 - Packager: Belvedere International Inc.
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated January 27, 2012
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ACTIVE INGREDIENT
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 473mLUSE 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ONE STEP HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60742-473 Route of Administration TOPICAL 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60742-473-01 473 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 01/27/2012 Labeler - Belvedere International Inc. (247836356) Establishment Name Address ID/FEI Business Operations Belvedere International Inc. 247836356 manufacture