CLASSIC CARE  BABY- 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 ®
Baby

Drug Facts

Active Ingredients

White Petrolatum USP 99.8%

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

Inactive Ingredients

Fragrance

PRINCIPAL DISPLAY PANEL - 368 g Bottle Label

Classic Care ®

Soft and gentle as a mother's embrace.

Baby Petroleum Jelly

NET WT 13 OZ (368g)

Principal Display Panel - 368 g Bottle Label
CLASSIC CARE   BABY
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60691-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum998 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60691-123-31368 g in 1 CONTAINER
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 & Investment Ltd675920690MANUFACTURE(60691-123)

Revised: 12/2013
Document Id: 2fd41533-9341-4f3a-ab97-4326adfb98a8
Set id: c275462a-0725-4ad8-9b9f-5b9bd9125c25
Version: 1
Effective Time: 20131203
 
FDN Enterprises, LLC