CLASSIC CARE  PETROLEUM- 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

Petrolatum USP 100%

Purpose

Skin Protectant

Uses

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

Distributed by:
FDN Enterprises, LLC.
Opa Locka, FL 33054.

PRINCIPAL DISPLAY PANEL - 510 g Jar Label

Unscented

Classic Care®

PETROLEUM JELLY

Skin Protectant

Net Wt 18 Oz (510g)

PRINCIPAL DISPLAY PANEL - 510 g Jar Label
CLASSIC CARE   PETROLEUM
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60691-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum100 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60691-126-34510 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/30/2011
Labeler - FDN Enterprises, LLC (965743867)
Establishment
NameAddressID/FEIBusiness Operations
Vikshara Trading & Investments Ltd675920690MANUFACTURE(60691-126)

Revised: 5/2015
Document Id: dcb5e20d-53f0-4ee9-9f5e-45c656cf3daf
Set id: 282893ee-8fe7-4f72-b1d0-3b4b9103b389
Version: 2
Effective Time: 20150508
 
FDN Enterprises, LLC