Label: BUDPAK PETROLEUM COCOA BUTTER- white petrolatum jelly
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Contains inactivated NDC Code(s)
NDC Code(s): 27293-029-02, 27293-029-03, 27293-029-04, 27293-029-14, view more27293-029-28, 27293-029-35, 27293-029-42 - Packager: Budpak Inc.
- 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 14, 2014
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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
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BUDPAK PETROLEUM COCOA BUTTER
white petrolatum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27293-029 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 99.9 g in 100 g Inactive Ingredients Ingredient Name Strength COCOA BUTTER (UNII: 512OYT1CRR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27293-029-14 1 in 1 BOX 1 14 g in 1 TUBE 2 NDC:27293-029-28 1 in 1 BOX 2 28 g in 1 TUBE 3 NDC:27293-029-35 1 in 1 BOX 3 35 g in 1 TUBE 4 NDC:27293-029-42 1 in 1 BOX 4 42 g in 1 TUBE 5 NDC:27293-029-02 1 in 1 BOX 5 113 g in 1 TUBE 6 NDC:27293-029-03 1 in 1 BOX 6 226 g in 1 TUBE 7 NDC:27293-029-04 453 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/14/2014 Labeler - Budpak Inc. (183224849) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(27293-029)