Label: ROYAL PETROLEUM (COCOA SCENT)- petrolatum jelly
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Contains inactivated NDC Code(s)
NDC Code(s): 50438-400-01 - Packager: Filo America
- 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 February 19, 2014
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROYAL PETROLEUM (COCOA SCENT)
petrolatum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50438-400 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) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MINERAL OIL (UNII: T5L8T28FGP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50438-400-01 198 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/19/2014 Labeler - Filo America (943873703) Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265) Establishment Name Address ID/FEI Business Operations NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265 manufacture(50438-400)