Label: PAN AROMAS BABY- mineral oil oil
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Contains inactivated NDC Code(s)
NDC Code(s): 50346-005-16, 50346-005-17, 50346-005-18, 50346-005-19, view more50346-005-20, 50346-005-21, 50346-005-22, 50346-005-23 - Packager: Pan Aromas 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 20, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAN AROMAS BABY
mineral oil oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50346-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 99.9 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50346-005-16 100 mL in 1 BOTTLE 2 NDC:50346-005-17 192 mL in 1 BOTTLE 3 NDC:50346-005-18 200 mL in 1 BOTTLE 4 NDC:50346-005-19 296 mL in 1 BOTTLE 5 NDC:50346-005-20 355 mL in 1 BOTTLE 6 NDC:50346-005-21 414 mL in 1 BOTTLE 7 NDC:50346-005-22 474 mL in 1 BOTTLE 8 NDC:50346-005-23 590 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/20/2012 Labeler - Pan Aromas LLC (078451131) Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(50346-005)
