Label: COOL MELON- allantoin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11084-042-27 - Packager: Deb USA, 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 October 6, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOL MELON
allantoin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ESTERS WAX (UNII: D072FFP9GU) PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CHLOROXYLENOL (UNII: 0F32U78V2Q) CARBOMER 934 (UNII: Z135WT9208) HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) (UNII: ZYD53NBL45) METHYLPARABEN (UNII: A2I8C7HI9T) ETHANOLAMINE (UNII: 5KV86114PT) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11084-042-27 1000 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/01/2010 Labeler - Deb USA, Inc. (607378015) Establishment Name Address ID/FEI Business Operations Deb USA, Inc. 607378015 manufacture