GLINT VITAMIN A AND D- white petrolatum ointment 
Glint Cosmetics 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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Drug Facts

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

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

Package Label

Principal Display

GLINT  VITAMIN A AND D
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71486-3045
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:71486-3045-25 g in 1 PACKET; Type 0: Not a Combination Product03/01/2018
2NDC:71486-3045-328.3 g in 1 TUBE; Type 0: Not a Combination Product03/01/2018
3NDC:71486-3045-4113 g in 1 TUBE; Type 0: Not a Combination Product03/01/2018
4NDC:71486-3045-5425 g in 1 JAR; Type 0: Not a Combination Product03/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2018
Labeler - Glint Cosmetics Private Limited (675910492)

Revised: 4/2018
Document Id: 69f25743-e1c3-dcf9-e053-2991aa0a41c5
Set id: 69f25881-d2f0-f20e-e053-2a91aa0ae258
Version: 1
Effective Time: 20180416
 
Glint Cosmetics Private Limited