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

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.

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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 finalpart34705/23/2013
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
Establishment
NameAddressID/FEIBusiness Operations
ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-307)

Revised: 12/2022
Document Id: ef7c5698-b8c3-a581-e053-2995a90a8c12
Set id: ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf
Version: 1
Effective Time: 20221210
 
ASTONEA LABS PRIVATE LIMITED