HYDROPHOR- petrolatum ointment 
Geritrex 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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Hydrophor Ointment

Drug Facts

Active Ingredients: Petrolatum 42%
Purpose: Skin protectant

Uses

• Rehydrates dry, chapped or chafed
skin.
• May be used alone as a skin lubricant
or protectant

Directions

Apply generously to affected areas
or as directed by your physician.

Apply generously to affected area

Warnings

For External Use Only.
When using this product:
• Avoid contact with eyes.
• If the condition worsens,
discontinue use and contact a
physician.

Ceresin, Lanolin Alcohol,
Microcrystalline Wax, Mineral Oil,
Phenoxyethanol

Store at room temperature (59°F-86°F).

KEEP OUT OF REACH OF CHILDREN

Label of Jar

HYDROPHOR 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM42 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERESIN (UNII: Q1LS2UJO3A)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-500-02100 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/31/2015
Labeler - Geritrex LLC (112796248)

Revised: 1/2016
Document Id: 83041600-dd68-4f97-b97a-3931eb2ab3c9
Set id: 79270fe6-115f-4830-82db-1dc1872cba9d
Version: 2
Effective Time: 20160108
 
Geritrex LLC