ILEX SKIN PROTECTANT- petrolatum cream 
Denison Pharmaceuticals, 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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Ilex Skin Protectant Paste

Active ingredient

White Petrolatum

Skin Protectant

Uses

Prevention and treatment of skin irritations and excoriations caused by urinary and fecal material. Can be used on both intact and broken skin. Will adhere to moist weeping wounds. Suitable for adults, children and babies.

Warnings

For external use only. Avoid contact with the eyes. Keep out of reach of children.

Keep out of reach of children

Inactive ingredients

Calcium / Sodium PVM / MA Copolymers, Corn Starch, Phenoxyethanol and Isopropyl Isobutyl Butylparabens, Sodium Carboxymethylcellulose, Zinc Oxide

See directions for use

label

ILEX SKIN PROTECTANT 
petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-4271
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM52.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISOPROPYL ISOBUTYRATE (UNII: IB2671N3UT)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-4271-1357 g in 1 TUBE; Type 0: Not a Combination Product02/12/2019
2NDC:0295-4271-017 g in 1 TUBE; Type 0: Not a Combination Product02/12/2019
3NDC:0295-4271-29227 g in 1 TUBE; Type 0: Not a Combination Product02/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/12/201902/23/2021
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-4271)

Revised: 2/2021
Document Id: bc049b78-788b-43d5-e053-2a95a90a458a
Set id: 81b9e40a-cec3-4e2f-e053-2a91aa0a057a
Version: 2
Effective Time: 20210223
 
Denison Pharmaceuticals, LLC