Label: JELL PHARMACEUTICALS VITAMIN A D- petrolatum ointment
- NDC Code(s): 30400-214-01, 30400-214-02, 30400-214-03, 30400-214-04
- Packager: Jell Pharmaceuticals Pvt. Ltd.
- 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 July 28, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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Purpose:
- Helps treat and prevent diaper rash
- Helps seal out wetness
- Temporarily protects minor * cuts * scrapes * burns
- Temporarily helps protect and help relieve chapped and cracked skin and lips
- Helps prevent and protect from the drying effects of wind and cold weather
- Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
- With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged
- Warnings:
- When using this product:
- Dosage & Administration
- Do not use:
- Keep out of reach of children
- Indications & Usage
- Other information:
- Inactive Ingredients:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
JELL PHARMACEUTICALS VITAMIN A D
petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30400-214 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 0.76 g in 1 g Inactive Ingredients Ingredient Name Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) CHOLECALCIFEROL (UNII: 1C6V77QF41) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30400-214-01 113.4 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2020 2 NDC:30400-214-02 425.25 g in 1 JAR; Type 0: Not a Combination Product 07/01/2020 3 NDC:30400-214-03 28.35 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2020 4 NDC:30400-214-04 56.7 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 04/24/2014 Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211) Registrant - jell pharmaceuticals pvt.ltd (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(30400-214)