Label: CREAMY COCOA BUTTER PETROLEUM JELLY- petrolatum cream
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Contains inactivated NDC Code(s)
NDC Code(s): 29500-2224-4 - Packager: Personal Care Products, 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 December 30, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients:
Water (aqua), mineral oil, glycerin, cetearl alcohol, cetyl alcohol, stearyl alcohol, glyceryl monostearate, fragrance, polysorbate 80, peregal O, butylated hydroxytoluene, methlparaben, propylparaben, dimethyl silicone oil, theobroma cacao (cocoa) seed butter, tocopheryl acetate
- PRINCIPAL DISPLAY PANEL
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CREAMY COCOA BUTTER PETROLEUM JELLY
petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-2224 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 30 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-2224-4 128 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/19/2011 Labeler - Personal Care Products, LLC (966155082) Establishment Name Address ID/FEI Business Operations Ningbo Liyuan Daily Chemical Products Co Ltd 530766098 manufacture