Label: CREAMY PETROLEUM- white petrolatum jelly
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-003-87 - Packager: Foodhold USA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 29, 2017
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- Active ingredient
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- Stop use and ask a doctor if
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INGREDIENTS AND APPEARANCE
CREAMY PETROLEUM
white petrolatum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM .30 mg in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) METHYLPARABEN (UNII: A2I8C7HI9T) DMDM HYDANTOIN (UNII: BYR0546TOW) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-003-87 127 g in 1 TUBE; Type 0: Not a Combination Product 01/29/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/29/2009 Labeler - Foodhold USA, LLC (809183973) Registrant - Vi-Jon, Inc (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, Inc 790752542 manufacture(41520-003) Establishment Name Address ID/FEI Business Operations American Blending 809226710 manufacture(41520-003)