PERSONAL CARE COCOA BUTTER SCENT- white petrolatum ointment 
Delta Brands & Products 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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Drug Facts

Active ingredient

White petrolatum USP (99.9%)

Purpose

Skin protectant

Uses

■ petroleum jelly restores smooth and healthy skin ■ helps to soothe dry, chapped, cracked or irritated skin and lips due to cold and wind ■ for the temporary protection of minor cuts, scrapes, burns and sunburn ■ helps to treat and prevent diaper rash

Warnings

For external use only

Avoid contact with eyes

Stop use and ask a doctor if

■ condition worsens or does not improve after 7 days

Keep out of reach of children

■ if swallowed get medical help or contact a Poison Control Center right away.

Directions

■ apply liberally, as often as necessary

Inactive Ingredients

fragrance

Package Label

Package Label

PERSONAL CARE  COCOA BUTTER SCENT
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-506
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72133-506-03100 g in 1 JAR; Type 0: Not a Combination Product04/09/2018
2NDC:72133-506-06170 g in 1 JAR; Type 0: Not a Combination Product04/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/09/2018
Labeler - Delta Brands & Products LLC (080999173)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Private Limited726025211manufacture(72133-506)

Revised: 4/2018
Document Id: 6a8ec25b-fce1-c6c1-e053-2991aa0a14ea
Set id: 6a8ec1cc-5b15-d7ae-e053-2a91aa0af039
Version: 1
Effective Time: 20180423
 
Delta Brands & Products LLC