ILEX SKIN PROTECTANT- petrolatum cream

ILEX Skin Protectant by

Drug Labeling and Warnings

ILEX Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

White Petrolatum

PURPOSE

Skin Protectant

INDICATIONS & USAGE

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

Warnings

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

See directions for use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ILEX SKIN PROTECTANT 
petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-4271
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	52.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-4271-13	57 g in 1 TUBE; Type 0: Not a Combination Product	02/12/2019
2	NDC: 0295-4271-01	7 g in 1 TUBE; Type 0: Not a Combination Product	02/12/2019
3	NDC: 0295-4271-29	227 g in 1 TUBE; Type 0: Not a Combination Product	02/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/12/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-4271)