Label: ONE STEP WIPES- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60742-200-01, 60742-200-02 - Packager: BELVEDERE INTERNATIONAL INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 December 13, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
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 0F
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ONE STEP WIPES
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60742-200 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:60742-200-02 12 in 1 PACKAGE 12/13/2018 1 NDC:60742-200-01 3 mL in 1 POUCH; Type 0: Not a Combination Product 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(60742-200)
