Label: ASTONEA VITAMIN A AND D- white petrolatum ointment
- NDC Code(s): 77338-307-02, 77338-307-03, 77338-307-04, 77338-307-05
- Packager: ASTONEA LABS PRIVATE LIMITED
- 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 10, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
-
Uses
■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or 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, espicially at bedtime when exposure to wet diapers may be prolonged
- Warnings
- When using this product
- Stop use and ask a doctor if
- Do not use on
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive ingredients
- Package Label
-
INGREDIENTS AND APPEARANCE
ASTONEA VITAMIN A AND D
white petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-307 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 76 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) LIGHT MINERAL OIL (UNII: N6K5787QVP) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CHOLECALCIFEROL (UNII: 1C6V77QF41) PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77338-307-02 5 g in 1 PACKET; Type 0: Not a Combination Product 05/23/2013 2 NDC:77338-307-03 28.3 g in 1 TUBE; Type 0: Not a Combination Product 05/23/2013 3 NDC:77338-307-04 113 g in 1 TUBE; Type 0: Not a Combination Product 05/23/2013 4 NDC:77338-307-05 425 g in 1 JAR; Type 0: Not a Combination Product 05/23/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/23/2013 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295) Establishment Name Address ID/FEI Business Operations ASTONEA LABS PRIVATE LIMITED 878533295 manufacture(77338-307)