Label: YOURS BABY FRESH SCENT PETROLEUM- white petrolatum jelly
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Contains inactivated NDC Code(s)
NDC Code(s): 71265-002-01, 71265-002-03, 71265-002-04, 71265-002-05, view more71265-002-06, 71265-002-07, 71265-002-08, 71265-002-09, 71265-002-10 - Packager: TRANSWORLD INTERNATIONAL TRADING CORP.
- 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 March 2, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
YOURS BABY FRESH SCENT PETROLEUM
white petrolatum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71265-002 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71265-002-01 50 g in 1 JAR; Type 0: Not a Combination Product 03/02/2017 2 NDC:71265-002-03 113 g in 1 JAR; Type 0: Not a Combination Product 03/02/2017 3 NDC:71265-002-04 170 g in 1 JAR; Type 0: Not a Combination Product 03/02/2017 4 NDC:71265-002-05 226 g in 1 JAR; Type 0: Not a Combination Product 03/02/2017 5 NDC:71265-002-06 283 g in 1 JAR; Type 0: Not a Combination Product 03/02/2017 6 NDC:71265-002-07 368 g in 1 JAR; Type 0: Not a Combination Product 03/02/2017 7 NDC:71265-002-08 425 g in 1 JAR; Type 0: Not a Combination Product 03/02/2017 8 NDC:71265-002-09 450 g in 1 JAR; Type 0: Not a Combination Product 03/02/2017 9 NDC:71265-002-10 500 g in 1 JAR; Type 0: Not a Combination Product 03/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/02/2017 Labeler - TRANSWORLD INTERNATIONAL TRADING CORP. (135417736) Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(71265-002)
