HYDROLATUM- white petrolatum cream

Hydrolatum by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

White Petrolatum, 54%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

• 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
• Keep out of reach of children
• Stop using if allergic

WHEN USING

• do not get into eyes
• do not get into mouth

STOP USE

• if condition lasts more than 7 days

DOSAGE & ADMINISTRATION

• apply as needed

OTHER SAFETY INFORMATION

• Store at 20-25C (68-77F)

INACTIVE INGREDIENT

Methylparaben, Purified Water, Sorbitan Sesquioleate

TROUBLESHOOTING

Call Toll Free at 1-800-601-3843 or email complaints@dpharm.net

DO NOT USE

• deep or punctured wounds
• animal bites
• serious burns

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROLATUM 
white petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	45 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9011-13	57 g in 1 TUBE; Type 0: Not a Combination Product	02/19/2020
2	NDC: 0295-9011-36	454 g in 1 JAR; Type 0: Not a Combination Product	02/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	02/19/2020

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-9011)