AG INTERNATIONAL VITAMIN A AND D- white petrolatum ointment 
AG International

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 N D MED

Active Ingredient

White Petrolatum 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

lanolin, lavender oil, light liquid paraffin, vitamin A, vitamin D

Package Label

Drug fact Panel

AG INTERNATIONAL  VITAMIN A AND D
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73235-3045
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)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
VITAMIN A (UNII: 81G40H8B0T)  
VITAMIN D (UNII: 9VU1KI44GP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73235-3045-25 g in 1 PACKET; Type 0: Not a Combination Product07/23/2019
2NDC:73235-3045-328.3 g in 1 TUBE; Type 0: Not a Combination Product07/23/2019
3NDC:73235-3045-4113 g in 1 TUBE; Type 0: Not a Combination Product07/23/2019
4NDC:73235-3045-5425 g in 1 JAR; Type 0: Not a Combination Product07/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/23/2019
Labeler - AG International (675480459)

Revised: 7/2019
Document Id: 8e110ca3-4aa2-577d-e053-2995a90ad294
Set id: 8e104ed7-0902-3e22-e053-2a95a90ac1c9
Version: 1
Effective Time: 20190723
 
AG International