Hydrolatum by Denison Pharmaceuticals, LLC Hydrolatum

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]

HYDROLATUM- white 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.

----------

Hydrolatum

White Petrolatum, 54%

Skin Protectant

  • temporarily protects and helps relieve chapped or cracked skin
  • helps prevent and protect from the drying effects of wind and cold weather

  • for external use only
  • Keep out of reach of children
  • Stop using if allergic

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

  • if condition lasts more than 7 days

  • apply as needed

  • Store at 20-25C (68-77F)

Methylparaben, Purified Water, Sorbitan Sesquioleate

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

  • deep or punctured wounds
  • animal bites
  • serious burns

Keep out of reach of children

label

HYDROLATUM 
white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0295-9347
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM45 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0295-9347-1357 g in 1 TUBE; Type 0: Not a Combination Product02/19/2020
2NDC: 0295-9347-36454 g in 1 JAR; Type 0: Not a Combination Product02/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/19/202009/12/2022
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-9347)

Revised: 9/2022
Document Id: e87d8d74-2150-45f1-e053-2995a90ac400
Set id: a951088c-db4f-7b87-e053-2a95a90a9cc7
Version: 2
Effective Time: 20220912
 

Trademark Results [Hydrolatum]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYDROLATUM
HYDROLATUM
76691543 3610776 Live/Registered
DENISON PHARMACEUTICALS, LLC
2008-07-24
HYDROLATUM
HYDROLATUM
74700964 2033025 Dead/Cancelled
Denison Pharmaceuticals, Inc.
1995-07-14
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.