HYDROPHOR by Akron Pharma Inc. / SLV PHARMACEUTICALS LLC HYDROPHOR ointment

HYDROPHOR by

Drug Labeling and Warnings

HYDROPHOR by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc., SLV PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient:

Petrolatum 42%

Purpose:

Skin protectant

Uses

• Helps prevent and protects chafed, chapped or cracked skin.
• Helps prevent and protect from the drying effects of wind and cold weather.

Warnings

For External Use Only.

INDICATIONS & USAGE

When using this product:

• Avoid contact with eyes.
• If the condition worsens, discontinue use and contact a physician.

KEEP OUT OF REACH OF CHILDREN

• KEEP OUT OF REACH OF CHILDREN.

Directions

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

Inactive Ingredient

Ceresin Wax, Lanolin, Mineral Oil, Paraffin Wax & Phenoxyethanol.

STORAGE AND HANDLING

Other Information

• Store at room temperature 15°-30°C (59°F-86°F).

QUESTIONS

Questions?

Please Call 1(877) 225-6999

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

Manufactured in U.S.A

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROPHOR 
hydrophor ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-5101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-5101-1	454 g in 1 JAR; Type 0: Not a Combination Product	02/03/2020
2	NDC: 71399-5101-2	100 g in 1 JAR; Type 0: Not a Combination Product	02/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/03/2020

Labeler - Akron Pharma Inc. (067878881)

Registrant - Akron Pharma Inc. (067878881)

Establishment
Name	Address	ID/FEI	Business Operations
SLV PHARMACEUTICALS LLC		081225162	manufacture(71399-5101)