Label: ONE STEP HAND SANITIZER ALOE- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 60742-001-01, 60742-001-02, 60742-001-03 - 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 September 11, 2013
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WARNINGS
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 400 C/1100F
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INGREDIENTS AND APPEARANCE
ONE STEP HAND SANITIZER ALOE
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60742-001 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) 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)