CLASSIC CARE PETROLEUM- white petrolatum jelly 
FDN Enterprises, LLC

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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Classic Care® Petroleum Jelly

Drug Facts

Active Ingredients

White Petrolatum USP (99.9%)

Purpose

skin protectant

Uses

• temporarily protects minor: • cuts • scrapes • burns • temporarily protects and helps relieve chapped or cracked skin and lips • helps protect from the drying effects of wind and cold weather.

Warnings

For external use only

When using this product • do not get into eyes.

Do not use on • deep or puncture wounds • laceration or infections • animal bites • serious burns

Stop use and ask doctor if condition lasts more than 7 days.

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

Directions:

apply as needed 

Inactive ingredients

Water 

PETROLEUM JELLY/ VASELINE

Unscented

Distributed by:

FDN Enterprises, LLC.

Opa Locka, FL 33054.

Made In India

Packaging

FDN-130

CLASSIC CARE PETROLEUM 
white petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60691-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60691-130-011 in 1 BOX09/15/2021
1510 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/15/2021
Labeler - FDN Enterprises, LLC (965743867)
Establishment
NameAddressID/FEIBusiness Operations
ORCHID LIFESCIENCES675474890manufacture(60691-130)

Revised: 9/2021
Document Id: cc251453-84d0-4d71-a5cd-2006e0278df5
Set id: 81238ed6-4fa9-4de7-a97e-67cfa66c08b6
Version: 1
Effective Time: 20210915
 
FDN Enterprises, LLC