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.

Inactive Ingredient

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

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

KEEP OUT OF REACH OF CHILDREN.

HP16C

HYDROPHOR
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54162-500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	42 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CERESIN (UNII: Q1LS2UJO3A)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
PARAFFIN (UNII: I9O0E3H2ZE)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54162-500-01	454 g in 1 JAR; Type 0: Not a Combination Product	07/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/31/2015

Labeler - Geritrex LLC (112796248)

Registrant - Geritrex LLC (112796248)

Name	Address	ID/FEI	Business Operations
Establishment
Geritrex LLC		112796248	manufacture(54162-500)