Label: CLASSIC CARE BABY- petrolatum jelly
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Contains inactivated NDC Code(s)
NDC Code(s): 60691-123-31 - Packager: FDN Enterprises, 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 3, 2013
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 368 g Bottle Label
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INGREDIENTS AND APPEARANCE
CLASSIC CARE BABY
petrolatum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60691-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum 998 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60691-123-31 368 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 05/30/2011 Labeler - FDN Enterprises, LLC (965743867) Establishment Name Address ID/FEI Business Operations Vikshara Trading & Investment Ltd 675920690 MANUFACTURE(60691-123)