ASTONEA VITAMIN A AND D- white petrolatum ointment 
ASTONEA LABS PRIVATE LIMITED

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VITAMIN A&D

Active Ingredient

White Petroleum Jelly USP (76% w/w)

Purpose

Skin Protectant

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

For external use only

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days

Do not use on

■ animal bites ■ deep or puncture wounds ■ serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

 for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

Other Information

■ store at 59-86F (15-30C) ■ avoid excessive heat and humidity

Inactive ingredients

Cholecalciferol, Lanolin, Light Mineral Oil, Microcrystalline Wax, Paraffin, Vitamin A Palmitate

Package Label

Principal Display and Drug Fact Panel

ASTONEA  VITAMIN A AND D
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-307
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-307-025 g in 1 PACKET; Type 0: Not a Combination Product05/23/2013
2NDC:77338-307-0328.3 g in 1 TUBE; Type 0: Not a Combination Product05/23/2013
3NDC:77338-307-04113 g in 1 TUBE; Type 0: Not a Combination Product05/23/2013
4NDC:77338-307-05425 g in 1 JAR; Type 0: Not a Combination Product05/23/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/23/2013
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
Establishment
NameAddressID/FEIBusiness Operations
ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-307)

Revised: 6/2024
Document Id: 1bbb6d64-77d3-86e2-e063-6294a90abdc4
Set id: ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf
Version: 2
Effective Time: 20240625
 
ASTONEA LABS PRIVATE LIMITED