PERSONAL CARE COCOA BUTTER- white petrolatum cream 
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

Petrolatum (30%)

Purpose

Skin protectant

Uses

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

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

■ deep or puncture wounds ■ animal bites ■ serious burns

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 (aqua), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, stearyl alcohol, glyceryl stearate, fragrance, ploysorbate-80, laureth-20, BHT, methyparaben,propylparaben, dimethicone, theobroma cacao (cocoa) seed butter, tocopheryl acetate

Package Label

Package Label

PERSONAL CARE  COCOA BUTTER
white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
LAURETH-20 (UNII: 6SU0SC83AH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72133-121-45127 g in 1 TUBE; 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)

Revised: 11/2018
Document Id: 79b67bee-e229-8d9c-e053-2991aa0a6b8b
Set id: 69972fb1-5482-a718-e053-2a91aa0ac602
Version: 2
Effective Time: 20181102
 
Delta Brands & Products LLC