ASTONEA-VITAMINS A AND D- 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.

----------

ASTONEA -Vitamins A and D

Drug Facts

Active ingredient

White Petrolatum USP (93.4%w/w)

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product

  • Do not get into eyes

Stop Use and consult a doctor if

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and reoccur in a few days

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children! If swallowed, get medical help or contact a Poison Control Center immediately

Directions for use with Diaper Rash

Other information

Inactive Ingredients

PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

ASTONEA-VITAMINS A AND D 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.934 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SOLVENT YELLOW 18 (UNII: L4SQI4K87S)  
LANOLIN (UNII: 7EV65EAW6H)  
PARAFFIN (UNII: I9O0E3H2ZE)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
VITAMIN A (UNII: 81G40H8B0T)  
VITAMIN D (UNII: 9VU1KI44GP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-105-325 g in 1 PACKET; Type 0: Not a Combination Product05/02/2022
2NDC:77338-105-33113 g in 1 TUBE; Type 0: Not a Combination Product05/02/2022
3NDC:77338-105-35425 g in 1 JAR; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/02/2022
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
Establishment
NameAddressID/FEIBusiness Operations
ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-105)

Revised: 5/2022
Document Id: dfb1f20a-19fe-5a6a-e053-2a95a90a46bf
Set id: de0b5b19-bbc5-4755-e053-2a95a90abfa1
Version: 2
Effective Time: 20220523
 
ASTONEA LABS PRIVATE LIMITED